Kidney stone treatment system

ABSTRACT

Kidney stone removal system is disclosed having components including a handle mechanism, a nozzle tip, and a guiding device. The handle mechanism employs a trigger that enables control of irrigation and vacuum/suction. Depression of a trigger in the trigger mechanism conveys status of vacuum/suction and irrigation to a user by providing increased resistance at different points of depression. When the trigger is in a home (undepressed) position, irrigation and vacuum/suction are turned off. When the trigger is in a fully depressed position, irrigation and vacuum/suction are turned on. When the trigger is in an intermediate position, irrigation may be turned on, while vacuum/suction remains turned off. The nozzle includes one or more irrigation ports positioned at a distal end of the nozzle and having an irrigation port departure angle of 30 to 60 degrees for directing irrigation fluid forward and laterally from the distal end of the nozzle. The guiding device is configured to be removably positioned in the nozzle for receiving a debris fragmentizing device, such as a laser device. The guiding device is configured to prevent an unintended movement of the fragmentizing device when the fragmentizing device is positioned in the nozzle while allowing fluid and debris to flow past the fragmentizing device and through a vacuum tube.

FIELD

The present inventions generally relate to systems, devices, and methodsfor guided removal of objects in vivo; and more particularly tomechanisms for irrigation and removal of objects, such as kidney stones.

BACKGROUND

Kidney stones are a common medical problem that negatively impactsmillions of individuals worldwide. Kidney stones include one or moresolid masses of material that are usually made of crystals and form inparts of the urinary tract including in the ureter, the kidney, and/orthe bladder of the individual. Kidney stones range in size from small(less than about 1 cm) to very large (more than 4 cm) and may causesignificant pain to the individual and damage to the kidney. Theoverwhelming majority of stones that are treated by surgeons are lessthan 1 cm.

The recommended treatment for removal of kidney stones varies accordingto numerous factors including the size of the kidney stones, the numberof kidney stones, and the location of the kidney stones. The most commontreatments for kidney stones are shock wave lithotripsy (ultrasoundwaves used to fracture the stones), ureteroscopy (fracture and removalof the stones using an endoscope that is introduced through thebladder), and percutaneous nephrolithotomy (fracture and removal of thestones using an endoscope that is introduced through a sheath placedthrough the patient's back into the kidney).

The largest kidney stones are usually removed through percutaneousnephrolithotomy or nephrolithotripsy. In these procedures, a smallincision is made through the patient's back adjacent the kidney and asheath is passed into the kidney to accommodate a larger endoscope usedto fracture and remove stones. The stone may be removed directly throughthe tube or may be broken up into small fragments while still in thepatient's body and then removed via a vacuum or other known methods.

There are numerous drawbacks associated with nephrolithotomy,nephrolithotripsy, and other invasive surgeries requiring an incision inthe skin. Namely, such surgical techniques may require significantlymore anesthesia administered to the patient, the surgeries are morecomplicated and pose a higher risk of infection and complications forthe patient, and the surgeries require a substantial incision in thepatient, which may leave a scar. Additionally, given the invasiveness ofthe procedure, percutaneous procedures are usually not preferred forsmaller kidney stones (e.g., less than 1 cm) depending on the size andlocation of the stones.

Traditionally, smaller kidney stones have been treated using lessinvasive techniques including through ureteroscopy. In ureteroscopy, thesurgeon typically inserts a ureteroscope into the urethra, through thebladder, and the ureter to provide the surgeon with a directvisualization of the kidney stones which may reside in the ureter orkidney. The surgeon then removes the kidney stone directly using abasketing device if the kidney stone is small enough to pass through theurinary tract without difficulty, or the surgeon fractures the kidneystone into smaller pieces using a laser or other breaking device. Alaser lithotripsy device is inserted through the ureteroscope and isused to fragmentize the larger kidney stones into smaller pieces. Afterbreaking the kidney stone into smaller pieces, the surgeon removes thelaser or breaking device and inserts a basket or an extraction catheterto capture the kidney stone fragments under the direct visualization ofthe ureteroscope. Upon retrieving some of the kidney stone fragments,the surgeon removes the basket from the patient and empties the kidneystone fragments therefrom. This process is repeated until clinicallysignificant kidney stones and kidney stone fragments are broken up andremoved from the body.

It should be apparent that this process is extremely time consuming,costly, and inefficient because the surgeon is required to insert andremove the scope and basket into and out of the patient many times tocompletely remove the kidney stones and kidney stone fragments. Using abasket removal device to capture kidney stones or kidney stone fragmentssuffers from other drawbacks in that the basket is difficult to positionadjacent the kidney stone fragments and maneuver in a manner thateffectively retrieves the fragments. The training required for such aprocedure is not insignificant and the basket removal technique can bedifficult for even the most skilled surgeons. Additionally, the surgeonis susceptible to hand fatigue due to the extended amount of timerequired to operate the kidney stone retrieval baskets. Further, thepatient is required to be under local anesthesia and/or remain immobileover an extended amount of time. Still further, the basket retrievaldevices cause irritation to the urinary tract due to the repeatedinsertion and removal.

Thus, there is an unmet need for new devices and methods that permitminimally invasive removal of kidney stones.

SUMMARY

In accordance with one aspect of the invention, a kidney stone removalmechanism is provided. The mechanism comprises an irrigation tube; avacuum tube; and a trigger mechanism. The trigger mechanism includes atrigger operable by a user. The trigger can be located at a proximal endof the kidney stone removal mechanism. The trigger mechanism can beoperable to selectively constrict, close, and open the irrigation tubeto irrigate an area of treatment upon user operation of the trigger, andto selectively initiate vacuum within the vacuum tube to remove partialor entire kidney stones upon user operation of the trigger. A userdepression of the trigger can progressively open the irrigation tube. Inan embodiment, the trigger comprises a first protrusion, such that auser operation of the trigger causes the first protrusion to selectivelyconstrict, close, and open the irrigation tube. The user depression ofthe trigger can cause the first protrusion to progressively open theirrigation tube. In an embodiment, the trigger can comprise a secondprotrusion, such that a user depression of the trigger causes the secondprotrusion to selectively initiate vacuum within the vacuum tube. Theuser depression of the trigger can cause the second protrusion toprogressively initiate vacuum within the vacuum tube. The kidney stoneremoval mechanism can further comprise

-   -   a catheter connected at its proximal end to a distal end of the        kidney stone removal mechanism. The catheter has a distal tip at        a distal end of the catheter. A steering mechanism can be        located at the proximal end of the kidney stone removal        mechanism. The steering mechanism is operable to steer the        distal tip to facilitate removal of partial or entire kidney        stones. The steering mechanism can comprise at least one wire,        connected between the steering mechanism and the catheter, to        move the distal tip to a desired location to facilitate removal        of partial or entire kidney stones.

The first protrusion can comprise a roller. The second protrusion cancomprise a roller. The trigger can comprise a third protrusion and thetrigger mechanism can comprise a first detent that is selectivelyengageable with the third protrusion, to alert the user to apredetermined amount of depression of the trigger. The first detent cancomprise an edge of a protrusion inside the trigger mechanism or cancomprise an edge of a depression inside the trigger mechanism. The thirdprotrusion of the trigger can comprise a roller. The kidney stoneremoval mechanism can further comprise a second detent to alert the userto a full amount of depression of the trigger. The second detent cancomprise the protrusion inside the trigger mechanism. The second detentcan comprise an opposite edge of the depression inside the triggermechanism. The roller can engage with the opposite edge of thedepression to alert the user to a full amount of depression of thetrigger.

In accordance with an embodiment, the trigger mechanism can be locatedat the proximal end of the kidney stone removal mechanism so as to beoperable by a user's thumb. The trigger mechanism can be located at theproximal end of the kidney stone removal mechanism so as to be operableby a user's finger. The steering mechanism can be located at theproximal end of the kidney stone removal mechanism so as to be operableby a user's thumb.

In accordance with an embodiment, the kidney stone removal mechanismfurther comprises a resilient device that interacts with the triggermechanism to cause the trigger mechanism to return to a home position inresponse to user release of the trigger. The resilient device cancomprise a spring.

In accordance with an embodiment, the kidney stone removal mechanismfurther comprises a vacuum activation tube connected to the vacuum tube.The second protrusion can initiate vacuum within the vacuum tube bypinching the vacuum activation tube shut. The second protrusion caninitiate vacuum within the vacuum tube by covering a port of the vacuumactivation tube.

In accordance with an aspect of the invention, a kidney stone removalmechanism is provided comprising an irrigation tube configured carryfluid and having a portion passing within a trigger mechanism and abypass structure connected in two places with the irrigation tube andconfigured to allow fluid to flow from a first part of the irrigationtube to a second part of the irrigation tube without passing through theportion of the irrigation tube within the trigger mechanism. The triggermechanism includes a trigger operable by a user. The trigger mechanismcan be operable to selectively constrict, close, and open the firstirrigation tube to irrigate an area of treatment upon user operation ofthe trigger. The bypass structure can comprise a flow restriction. Auser depression of the trigger can progressively open the irrigationtube. The kidney stone removal mechanism can further comprise a vacuumtube configured to be activated by the trigger mechanism. The kidneystone removal mechanism can further comprise a catheter connected at itsproximal end to a distal end of the kidney stone removal mechanism, thecatheter having a distal tip at a distal end of the catheter, and

-   -   a steering mechanism, located at the proximal end of the kidney        stone removal mechanism, the steering mechanism operable to        steer the distal tip to facilitate removal of partial or entire        kidney stones.

In accordance with another aspect of the invention, a kidney stoneremoval mechanism is provided comprising an irrigation tube; a vacuumtube; and a flow indicator mechanism including a flow indicatorconnected to a stone catcher assembly. In an embodiment, the flowindicator can comprise one or more vanes that move in response to fluidor air flow. The kidney stone removal mechanism can further comprise acatheter connected at its proximal end to a distal end of the kidneystone removal mechanism, the catheter having a distal tip at a distalend of the catheter, and a steering mechanism, located at the proximalend of the kidney stone removal mechanism, the steering mechanismoperable to steer the distal tip to facilitate removal of partial orentire kidney stones.

In accordance with one aspect, the kidney stone removal mechanism canfurther comprise a nozzle. The nozzle can include a vacuum lumen incommunication with the vacuum tube and sized to remove kidney stones orfragments of kidney stones, and one or more irrigation ports incommunication with the irrigation tube, the irrigation ports positionedat a distal end portion of the nozzle and having an irrigation portdeparture angle in the range of 30 to 60 degrees for directingirrigation fluid forward and laterally from the distal end portion ofthe nozzle. In an embodiment, at least one of the irrigation ports has ashape of an arc.

In accordance with another aspect of the invention, a kidney stoneremoval mechanism is provided, comprising a kidney stone removalcatheter and a nozzle assembly included at a distal end of the catheter.The nozzle can comprise a vacuum lumen sized to remove kidney stones orfragments of kidney stones, and one or more irrigation ports at a distalend portion of the nozzle. At least one of the irrigation ports has anirrigation port departure angle in the range of 30 to 60 degrees fordirecting irrigation fluid forward and laterally from the distal endportion of the nozzle. In an embodiment, the kidney stone removalmechanism comprises a first irrigation port configured to directirrigation fluid forward but not in a radially diverging direction and asecond irrigation port configured to direction irrigation fluid in aradially diverging direction. In an embodiment, at least two of theirrigation ports have a different opening size, are of a differentshape, and/or have a different irrigation port departure angle. In oneembodiment, the first of the irrigation ports is one of circular,elliptical, or arc-shaped and a second of the irrigation ports has adifferent shape than the first irrigation port and is one of circular,elliptical, or arc-shaped. The first irrigation port can be positioneddirectly between a second and third irrigation ports, wherein the arcdistance between the first and second irrigation ports is different thanthe arc distance between the first and third irrigation ports.

In an embodiment, the kidney stone removal mechanism additionallycomprises an image sensor and a light source. The nozzle can include anupper recess for receiving the image sensor and the light source. Thekidney stone removal mechanism can additionally comprise a distalmanifold configured to be inserted within a proximal end of the nozzle,the distal manifold having conduits for directing irrigation fluid tothe irrigation ports of the nozzle. The kidney stone removal mechanismcan additionally comprise a shaft manifold configured to connect to thedistal manifold, the shaft manifold having irrigation lumens forchanneling irrigation fluid to the conduits of the distal manifold.

The nozzle can include a distal face having radiused or curved edges.The vacuum lumen can be offset from the center of the nozzle. The nozzlecan comprise at least one conduit for providing a fluid path between thecatheter and the irrigation ports. The at least one conduit can comprisea divider for directing fluid to the irrigation ports.

In accordance with one aspect of the invention, a kidney stone removalsystem is provided, comprising a vacuum tube and a laser guideconfigured to be removably inserted into the vacuum tube. The laserguide comprises a tubular body having a lumen configured to receive alaser device, and wings extending from a distal end segment of thetubular body for guiding the distal end segment of the tubular body inthe vacuum tube and creating flow gaps between the tubular body and thevacuum tube.

In one embodiment, the tubular body is configured to not extend out of adistal end of the vacuum tube when the tubular body is insertedcompletely into the vacuum tube and placed in an operational position.In one embodiment, the guide comprises two to four wings. In oneembodiment, the guide consists of three or four wings and acircumferential distance is the same between each pair of neighboringwings. In one embodiment, the guide consists of three or four wings andthe circumferential distance between a first pair of the neighboringwings is different from a circumferential distance between a second pairof neighboring wings. The first pair and second pair of neighboringwings can share a common wing. In some embodiments, at least two of thegaps have different sizes.

In one embodiment, each wing comprises a middle segment having arectangular shape, which transitions into tapered end segments thatslope downward into the tubular body. In some embodiments, each wing hasa variable thickness that increases from a proximal end of the wing to adistal end of the wing along a longitudinal axis. In some embodiments,each wing has a longitudinal axis that is at an angle relative to alongitudinal axis of the tubular body.

In accordance with another aspect of the inventions, the kidney stoneremoval system additionally comprising an actuator for moving thetubular body within the vacuum tube. In one embodiment, the actuatorcomprises a biasing element and a shaft coupled to the tubular body,such that actuation of the biasing element causes the shaft to move thetubular body in a back-and-forth direction within the vacuum tube. Inone embodiment, the shaft is configured to be removably coupled to aproximal end of the tubular body. In an alternative embodiment, theshaft is permanently attached to a proximal end of the tubular body.

In one embodiment, the biasing element comprises a band coupled to adistal section of the shaft. The actuator can additionally comprise acylindrical housing coupled to the band and configured to receive theshaft, such that an inward compression and release of the band causes apart of the shaft to telescopically move into and out from thecylindrical housing. The actuator comprises a channel for receiving thelaser device. The channel is configured to be in commutation with thelumen of the tubular body.

In accordance with another aspect of the invention, a catheter assemblyis provided comprising a vacuum tube and a guiding device configured tobe removably positioned in the vacuum tube for receiving a debrisfragmentizing device. The guiding device is configured to prevent anunintended movement of the fragmentizing device when the fragmentizingdevice is positioned at a distal end of the vacuum tube, while allowingfluid and debris to flow past the fragmentizing device and through thevacuum tube. The catheter system can additionally include an actuatingdevice for moving the guiding device within the vacuum tube forclearance of debris. The fragmentizing device can be a laser fiber.

In accordance with another aspect of the invention, a method of kidneystone removal with the use of all of the embodiments of the presentinventions is provided. In accordance with an aspect of the invention,methods of kidney stone removal are provided comprising operating kidneystone removal mechanisms as described above and herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects of the present invention now will be described in detail withreference to the accompanying drawings, which are not drawn to scale:

FIG. 1 is a perspective schematic of the kidney stone treatment systemaccording to an embodiment;

FIG. 2 is a perspective view of a kidney stone removal mechanismaccording to an embodiment;

FIG. 3 is a rear view of the mechanism shown in FIG. 2 ;

FIG. 4 is a side view of the mechanism shown in FIG. 2 ;

FIG. 5 is a front view of the mechanism shown in FIG. 2 ;

FIG. 6 is an exploded view of a trigger activation mechanism accordingto an embodiment;

FIGS. 7 to 9 show successive positions of a trigger according to anembodiment;

FIG. 10 is a reverse view of a trigger activation mechanism according toan embodiment;

FIGS. 11 and 12 show successive positions of a trigger in a triggeractivation mechanism according to an embodiment;

FIGS. 13 and 14 show successive positions of a trigger in a triggeractivation mechanism according to an embodiment;

FIG. 15 is a picture of a trigger activation mechanism according to anembodiment;

FIG. 16 is a front view of the kidney stone removal mechanism of anembodiment;

FIG. 17 is a side view of the kidney stone removal mechanism of anembodiment;

FIG. 18 is a rear view of the kidney stone removal mechanism of anembodiment;

FIGS. 19 to 21 show successive positions of a trigger according to anembodiment;

FIG. 22 is a close-up perspective view of the trigger and a distal tipcontrol mechanism in FIGS. 16 to 21 ;

FIG. 23 is an exploded view of a trigger mechanism according to anembodiment;

FIG. 24 is an assembled view of the trigger mechanism of FIG. 23 ;

FIGS. 25 to 27 show successive positions of a trigger mechanismaccording to an embodiment;

FIG. 28 shows a kidney stone treatment system according to anembodiment;

FIG. 29 shows a portion of a kidney stone removal mechanism of FIG. 28 ;

FIG. 30 shows a view of a portion of a kidney stone removal mechanismaccording to an embodiment;

FIGS. 31 to 34 show successive positions of a trigger in the structureof FIG. 30 according to an embodiment;

FIGS. 35 and 36 show schematic diagrams of a vacuum/suction controlsystem and method according to an embodiment;

FIGS. 37 and 38 show successive positions of a trigger in a triggeractivation mechanism according to an embodiment;

FIG. 39 shows a flow bypass structure of a mechanism according to anembodiment;

FIG. 40 shows a cross section of a flow bypass structure of a mechanismaccording to an embodiment;

FIG. 41 shows a cross section of a flow bypass structure of a mechanismaccording to an embodiment;

FIG. 42 shows a cross section of a flow bypass structure of a mechanismaccording to an embodiment;

FIG. 43 is a view of a kidney stone removal mechanism according to anembodiment;

FIG. 44 is a rotated and enlarged view of a portion a kidney stoneremoval mechanism according to an embodiment;

FIG. 45 is an exploded view of a stone catcher assembly according to anembodiment;

FIGS. 46 and 47 are two views of a flow indicator mechanism according toan embodiment;

FIGS. 48A and 48B are perspective views of a distal assembly inaccordance with an embodiment;

FIGS. 49A and 49B are perspective and perspective exploded views of adistal assembly in accordance with an embodiment;

FIGS. 50A, 50B, and 50C are end sectional views of the distal assemblyin accordance with an embodiment;

FIGS. 51A, 51B, 52A, 52B, 53A, 53B, 54A, 54B, 55A, 55B, 56, 57, 58A,58B, 59A, and 59B illustrate nozzle tips in accordance with variousembodiments;

FIG. 60 illustrates a distal assembly according to an embodiment;

FIG. 61 illustrates a distal assembly according to an embodiment;

FIGS. 62A, 62B, and 62C illustrate views of an embodiment of a nozzletip of a distal assembly;

FIG. 63A illustrates a schematic of a test apparatus for measuringaffected area of nozzle tip designs;

FIG. 63B is a photograph of test results when measuring affected area ofnozzle tip designs;

FIG. 64 illustrates a cross-sectional view of a section of the cathetershaft assembly;

FIG. 65 is a partial perspective view of an embodiment of a guide;

FIG. 66 is a front-end view of an embodiment of the guide;

FIG. 67 is a schematic front-end view of an embodiment of the guidepositioned inside of a vacuum tube;

FIG. 68 is a schematic view of a distal section of an embodiment of theguide;

FIGS. 69A and 69B are top plan views illustrating various embodiments ofwings or extensions for the guide;

FIG. 70 is a partial side plan view of an embodiment of the guide;

FIG. 71A is a perspective view of an embodiment of an actuator toactuate the guide;

FIG. 71B is a top plan view of an embodiment of the actuator; and

FIG. 72 is a perspective view of an embodiment of the actuator.

DESCRIPTION

Disclosed herein are systems, devices, and methods for the guidedremoval of objects in vivo. In particular, the systems, devices, andmethods may be adapted to traverse compact areas, such as the urinarytract, and to remove debris, such as kidney stones or fragments ofkidney stones, via aspiration through a vacuum tube. As used herein, theterm “kidney stones” may refer to fragments of kidney stones, includingfragments that have been created by therapeutic fracturing of kidneystones, such as with the device described herein or by another device.

FIG. 1 illustrates an embodiment of a treatment system 10 used to removedebris, such as kidney stones. The system 10 includes a handle mechanism12 from which a catheter 14 extends. The system 10 includes a handlemechanism 12 from which a catheter 14 extends. In the embodimentsdescribed below, the handle 12 can be configured to provide, forexample, a single trigger design comprising, or consisting of, twomodes: an active irrigation mode only (i.e., active irrigation on/vacuumoff) and an active irrigation mode in combination with a vacuum mode(i.e., active irrigation on/vacuum on). In the embodiments describedbelow, the handle 12 can be configured to provide, for example, a singletrigger design comprising, or consisting of, three modes: passiveirrigation on/active irrigation off/vacuum off; passive irrigationon/active irrigation on/vacuum off; passive irrigation on/activeirrigation on/vacuum on. In an embodiment, there may be a minimum,passive amount of negative pressure even in the modes where the vacuumis off. Some aspects of the flow design allow for an uninterruptedconduit between the end of the device and the vacuum source such thatthere is high flow when vacuum is activated and minimal or no flow whenvacuum is not activated. The catheter 14 can include various ports andlumens, including a vacuum lumen and an irrigation lumen running alongthe length of the catheter 14. The system 10 can also include a camera(digital visualization and lighting, e.g., video chip and LED)positioned at an end, distal face or a distal portion of the catheter 14for providing real time imaging to the physician. A distal assembly 16is at the distal end of the catheter 14 for irrigation and removal ofthe debris, with the assistance of the negative pressure applied throughthe vacuum lumen. The handle mechanism 12 allows the physician to holdand operate the system 10. The handle mechanism 12 can include featuresthat allow a physical to operate various functions of the system,including the camera, vacuum pressure, the amount of irrigation andirrigation pressure, and the maneuverability of the catheter 14. Forexample, the handle mechanism 12 can include mechanical and electroniccontrols that allow the physician to adjust the amount of negativepressure, regulate the discharge of the irrigation fluid, and steer thecatheter through tortuous anatomical passageways via the use of wheelsand/or levers attached to cables, as is well known in the art. Thesystem 10 can be coupled to a control unit 18 via a connector 20. Thecontrol unit 18 can control or assist in controlling aspects of theoperation of the system 10. For example, the control unit 18 can controlor assist in controlling visualization aspects of the system 10. Theconnector 20 can be a wired connection and/or a wireless connection.

Handle Mechanism

FIG. 2 shows the handle mechanism 12 for effecting kidney stone removalaccording to an embodiment. A finger grip portion 22 runs a portion of alength of the mechanism 12. An optional ledge portion 24 sits over wherea user's hand would be while gripping the mechanism 12. Above theoptional ledge portion 24 is a trigger 26, which is a part of a triggermechanism to be described later. The trigger mechanism controls vacuum(or suction) and air flow, as well as irrigation operation of themechanism 12. A user may operate the trigger 26 with one of theirfingers. A distal tip steering control 28 sits at a proximal end portionof the mechanism 12. A user's thumb may control the positioning and/orsteering of the distal tip of a catheter by manipulating a lever 30.Various types of catheters may be employed with the mechanism 12,including but not limited to those shown and described in U.S. Pat. No.11,116,530. U.S. Pat. No. 11,116,530 shows and describes one or morepull wires, which can steer the distal tip of a catheter throughmanipulation of the lever 30 to which the one or more pull wires may beattached. FIG. 2 also shows a vacuum/suction port 32 and an irrigationport 34, as well as a catheter strain relief 36. A stone catcherreceptacle 38 receives extracted kidney stones and/or fragments througha port 40. An access or working channel port 42 permits access to thecatheter (not shown) to allow introduction of therapeutic tools such aslasers to the distal end of the catheter.

FIG. 3 shows a rear view of the handle mechanism 12. In FIG. 3 , thevacuum port 32, irrigation port 34, and catheter strain relief 36 arevisible, as are the stone catcher receptacle 38 and distal tip steeringcontrol 28. FIG. 4 shows a side view of the mechanism 12. In FIG. 4 ,many of the same elements are visible as in FIG. 2 . The finger gripportion 22, with the ledge portion 24 sitting above, fits a user's handabove the access or working channel port 42. The vacuum port 32,irrigation port 34, and catheter strain relief 36 sit at the bottom ofthe mechanism 12, behind the stone catcher receptacle 38. The port 40,which deposits kidney stones, or fragments or portions of kidney stones,into the stone catcher receptacle 38, also is visible. In FIG. 5 , whichis a front view of the mechanism 12, many of the same elements arevisible as in FIG. 2 . The finger grip portion 22, with the ledgeportion 24 sitting above, fits a user's hand above the access or workingchannel port 42. The catheter strain relief 36 sits at the bottom of themechanism 12, behind the stone catcher receptacle 38. The port 40, whichdeposits kidney stones or portions of kidney stones into the stonecatcher receptacle 38, also is visible.

FIG. 6 is an exploded view of a portion at the top of the mechanism 12.Collectively, the parts in FIG. 6 constitute a trigger mechanismassembly 44. Going from top to bottom in FIG. 6 , a screw or bolt 46passes through a washer 48 and opening 50 of a trigger mechanism 52. Thetrigger mechanism 52 includes protrusions 54, 56, and 58. The functionof these protrusions during actuation of the trigger mechanism 52 willbe described in more detail below with respect to FIGS. 7-9 . The screwor bolt 46 also passes through a spring 60 or other resilient device andis received by a screw/bolt receptacle 62. In some examples, the bolt 46holds the trigger securely to a base plate boss that captures the spring60. The spring 60 provides resilience for the trigger mechanism 52, sothat the trigger mechanism 52 returns to its original, home positionwhen a user releases or removes pressure from the trigger 26. The spring60 or other resilient device sits in opening 64 of a mechanism casing orbody 66. The mechanism body 66 also includes first and second detents 68and 70, whose function will be described in more detail below withrespect to FIGS. 7-9 . In some examples, the mechanism body 66 maycontain more or fewer detents. When the handle mechanism 12 isassembled, mechanism casing 66 is not visible. In FIG. 6 and insubsequent figures, the mechanism casing 66 is exposed for ease ofdescription of the function of the trigger mechanism 52. An irrigationtube (not shown) enters through opening 72, proceeds through opening 74,under a covering portion 76, and exits through an opening 78. A vacuumactivation tube (not shown) sits inside the mechanism casing 66, andexits through opening 80.

Advancing to FIGS. 35 and 36 , they show schematic diagrams of avacuum/suction control system and method 82. A suction outlet tube 84includes a suction opening 86, which is connected to a vacuum/suctionsource (not pictured). Flow through the suction outlet tube 84 is in thedirection of arrow S. A suction target tube 88 includes a target opening90, which is connected to a portion of the device that is in proximityof an area targeted for suction/vacuum. FIG. 36 shows a configuration inwhich flow through suction target tube 88 is in the direction of arrowT. An activation tube 92 includes an activation opening 94, which isopen to ambient air. An activation pinch mechanism 96 is positionedadjacent to the activation tube 92 and is movable in the direction ofarrow P from first position that allows flow in the direction of arrow Bthrough the activation tube 92 (shown in FIG. 35 ) and a second positionthat prevents flow from activation opening 94 through activation tube 92(shown in FIG. 36 ). The system and method 82 shows that the activationpinch mechanism 96 allows for control over the vacuum/suction flow. Thevacuum source (not pictured) can be set to a provide a constant amountof suction (e.g., 200 mmHg) and the activation pinch mechanism 96provides for on/off control over the vacuum/suction by opening orclosing the activation tube 92. In the configuration shown in FIG. 35 ,the activation pinch mechanism 96 is positioned such that air flowsthrough the activation tube 92 in the direction of arrow B, through thesuction outlet tube 84 in the direction of arrow S, and out to thevacuum/suction source. In the configuration shown in FIG. 35 , little orno flow is through the suction target tube 88 from the targeted area tothe suction outlet tube 84. In the configuration shown in FIG. 35 ,there is no (or comparatively little) suction applied to the target areaand vacuum is off at the target area. In the configuration shown in FIG.36 , the activation pinch mechanism 96 is positioned such that no airflows through the activation tube 92. In the configuration shown in FIG.36 , all the flow is through the suction target tube 88 from thetargeted area in the direction of arrow T to the suction outlet tube 84and out the suction opening 86 in the direction of arrow S. In theconfiguration shown in FIG. 36 vacuum is on at the target area.

FIGS. 7-9 show successive positions of the trigger 26. In FIG. 6 , thetrigger 26 is in the undepressed position. With the trigger 26 in thatposition, the vacuum and irrigation in the handle mechanism 12 areturned off. In some examples, an irrigation bypass structure may allowfor a minimum amount of irrigation to flow even when trigger 26 is inthe undepressed position. The protrusion 54 pinches off an irrigationtube 98. The protrusion 56 is not in contact with the detent 68. Theprotrusion 58 may contact, but does not compress, a vacuum activationtube 100 (see also, for example, the activation tube 92 of FIGS. 35 and35 ). The vacuum activation tube 100 is open to ambient air at one endand connected at an end 102 with vacuum tubing running from a vacuumsource to a vacuum lumen running to the vacuum target area. The spring60 or other resilient device engages the trigger mechanism 52resiliently so that, when the user releases the trigger 26, the trigger26 returns to its initial position, so that irrigation and vacuum areturned off. In some embodiments, irrigation is partially on at a minimumlevel and vacuum is off when the trigger 26 returns to its initialposition. In FIG. 8 , the trigger 26 is partly depressed, up to thepoint that the protrusion 56 contacts detent 68 in the mechanism body66, indicating to the user that a first stopping point in operation hasbeen reached. With the trigger 26 in this position, the protrusion 54partly disengages with the irrigation tube 98, opening the irrigationtube 98 slightly, and allowing for some irrigation (or, in someembodiments, full irrigation flow). The protrusion 58 partly closes offthe vacuum activation tube 100, but air still can flow through thevacuum activation tube 100, so vacuum at the target area still is off.In FIG. 9 , the trigger 26 is fully depressed. The protrusion 56proceeds past the detent 68 and seats up against the detent 70. In thisposition, the protrusion 58 pinches off the vacuum activation tube 100,thereby turning the vacuum on at the target area. The protrusion 54opens the irrigation tube 98 further, so that irrigation continues, andkidney stones and/or pieces of kidney stones can be removed anddeposited in the stone catcher receptacle 38 (FIGS. 2-5 ). FIG. 10 showsa view of the mechanism body 66 from an opposite side to those shown inFIGS. 7-9 . The irrigation tube 98 has an inlet 104 and an outlet 106.The activation tube 100 runs through the mechanism body 66. The trigger26 has protrusions (not shown) which interact with the irrigation tube98 and the activation tube 100 according to a degree of depression ofthe trigger 26. In the foregoing descriptions of kidney stone removalmechanism, the function of the inlet 104 and the outlet 106 can bereversed, so that element 104 operates as an irrigation outlet, andelement 106 operates as an irrigation inlet.

FIG. 11 shows a portion of a kidney stone removal mechanism 108according to an embodiment. A mechanism casing or body 110 contains anirrigation tube 112 with an irrigation inlet 114 and an irrigationoutlet 116. A trigger 118 has a protrusion 120 which interacts with theirrigation tube 112. When the trigger 118 is undepressed, as shown inFIG. 11 , the protrusion 120 closes off, or at least constricts, theirrigation tube 112. A spring 122 or other resilient device movesagainst the force of a user depression of trigger 118 to return thetrigger 118 to its undepressed state when the user releases the trigger118. When depressed, the trigger 118 rotates around a pivot point 124,causing the protrusion 120 to move away from the irrigation tube 112 toopen the tube and enable irrigation. FIG. 12 shows structure similar tothat in FIG. 11 , except that in FIG. 12 , the trigger 118 is depressed,so that the protrusion 120 moves away from the irrigation tube 112 toopen it up. FIG. 13 shows structure similar to that in FIG. 11 , butfrom an opposite side of the mechanism body 110. The trigger 118 is inthe same position in FIG. 13 as in FIG. 11 . When the trigger 118 is inthis position, a vacuum tube (not shown) in position 126 will not bepinched, so that vacuum or suction will be off. Comparing FIG. 13 withFIG. 11 , when vacuum or suction is off, so is irrigation. FIG. 14 showsstructure similar to that in FIG. 13 , except that in FIG. 14 , thetrigger 118 is depressed, so that the vacuum tube (not shown) inposition 126 will be pinched, so that vacuum or suction will be on.Comparing FIG. 14 with FIG. 12 , when vacuum or suction is on, so isirrigation, similarly to other described embodiments.

Unlike the embodiment of FIGS. 7 to 9 , FIGS. 11 to 14 do not show anintermediate depression position for the trigger 118. However,ordinarily skilled artisans will appreciate that kidney stone removalmechanism 108 enables a range of depression positions for trigger 118.Accordingly, similarly to the embodiment of FIGS. 7 to 9 , there is anintermediate depression for the trigger 118, whereby the irrigation tube112 will be slightly un-pinched, allowing irrigation to flow, while thevacuum tube (not shown) will be slightly pinched, so that vacuum orsuction still will be off.

FIG. 15 is a photograph of a portion of the kidney stone removalmechanism 108, similar to the structure in FIG. 11 , according to anembodiment. The mechanism body 110 contains the irrigation tube 112 withthe irrigation inlet 114 and the irrigation outlet 116. The trigger 118has the protrusion 120 which interacts with the irrigation tube 112.When the trigger 118 is undepressed, as shown in FIG. 15 , theprotrusion 120 closes off, or at least constricts, the irrigation tube112. The spring 122 or other resilient device moves against the force ofa user depression of the trigger 118 to return the trigger 118 to itsundepressed state when the user releases the trigger 118. Whendepressed, the trigger 118 rotates around the pivot point 124, causingthe protrusion 120 to move away from the irrigation tube 112 to open upthe tube and enable irrigation. The trigger 118 is in the same positionin FIG. 15 as in FIG. 13 . When trigger 118 is in this position, avacuum tube (not shown) in position 126 will not be pinched, so thatvacuum or suction will be off. When vacuum or suction is off, so isirrigation. In the foregoing descriptions, the function of the inlet 114and the outlet 116 can be reversed, so that element 114 operates as anirrigation outlet, and element 116 operates as an irrigation inlet.

FIGS. 16-22 show a kidney stone removal mechanism 128 according to anembodiment. A finger grip portion runs a portion of the length ofmechanism. A trigger mechanism 130 is located at a proximal end of thekidney stone removal mechanism 128. A distal tip steering mechanism 132,also located at a proximal end of the kidney stone removal mechanism128, enables manipulation of a catheter, particularly a distal end of acatheter, to position the distal end as desired for kidney stonefracture and/or removal. The catheter is connected to catheter strainrelief 134. A stone catcher receptacle 136 receives removed kidneystones and/or pieces thereof. A working channel port 138 permits accessto the catheter for insertion of devices and tools. In FIG. 16 , showinga front view of the kidney stone removal mechanism 128, there is a moredetailed view of the catheter strain relief 134. There also is a frontview of the stone catcher receptacle 136. The access or working channelport 138 permits access to a catheter to allow introduction oftherapeutic tools such as lasers to the distal end of the catheter. FIG.16 also shows a front view of the trigger 130, and a side view of thedistal tip steering mechanism 132. FIG. 17 shows a side view of thekidney stone removal mechanism 128. A vacuum outlet 140 and irrigationinlet 142 are visible, as well as the catheter strain relief 134, thestone catcher receptacle 136, and a finger grip 143. In FIG. 18 ,showing a rear view of the kidney stone removal mechanism 128, thevacuum outlet 140 and the irrigation inlet 142 are visible, as is thecatheter strain relief 134. The distal tip steering mechanism 132 alsois visible. FIGS. 19-21 show close ups of successive positions of thetrigger 130 of the kidney stone removal mechanism 132, from undepressedin FIG. 19 to fully depressed in FIG. 21 . FIG. 22 shows a perspectiveside view of FIGS. 19-21 .

FIG. 23 shows an exploded view of a trigger mechanism assembly 144according to an embodiment. A bolt 146 and a washer 148 pass through aslot 150 in a trigger mechanism 152. An irrigation tube 154 has anirrigation inlet and irrigation outlet 166 and 168. A spring 156 biasesa trigger 158 toward an undepressed position. A pivot 160 receives thetrigger mechanism 152 by fitting through a hole 162 in the triggermechanism 152. When a user actuates the trigger 158, the triggermechanism 152 rotates around the pivot 160. An opening 164 leads to avacuum outlet (not shown). FIG. 24 shows an assembled version of thetrigger mechanism of FIG. 23 . Elements discussed above with respect toFIG. 23 are depicted with the same reference numerals in FIG. 24 .

FIGS. 25-27 show successive positions of the trigger 158 for the triggermechanism 144, from undepressed in FIG. 25 to fully depressed in FIG. 27, with corresponding movement of relevant parts. In FIG. 25 , thetrigger 158 is in its normal position, resulting from bias that thespring 156 or other resilient device (shown in previous Figures)applies. A roller 167 is mounted on a pin 169, at one end of a bar orlever 170. At the other end 172 of the bar or lever 170 is a mount 174to which the bar or lever 170 is attached. With this structure, the baror lever 170 pivots around the mount 174 when trigger 158 is depressed.Also in FIG. 25 , the roller 167 is positioned away from the opening164, which leads to a vacuum outlet (not shown). The roller 167depresses the irrigation tube 154, closing off irrigation. Accordingly,in the trigger position shown in FIG. 25 , both irrigation and vacuumare turned off. FIG. 25 further illustrates protrusions 176 and 178, thefunction of which is described with reference to FIGS. 26 and 27 . FIG.26 shows an intermediate position of the trigger 158, with acorrespondingly intermediate position of the roller 167, closer to theopening 164. Depression of the trigger 158 causes the bar or lever 170to rotate around the mount 174. Depression of the trigger 158 to theextent shown in FIG. 26 causes the roller 167 to come into contact withthe protrusion 178, providing more resistance and signaling to the userthat the trigger 158 is in an intermediate position. In this position,the roller 167 exerts less pressure on irrigation tube 154. Accordingly,in the trigger position shown in FIG. 26 , vacuum still is turned off,but irrigation begins to be turned on. FIG. 27 shows a fully depressedposition of the trigger 158. In this position, the user depressing thetrigger 158 has caused the roller 167 to proceed over protrusion 178, tocover the opening 164, and to move farther away from the irrigation tube154. The roller 167 moves up against the protrusion 176, signifying tothe user that the trigger 158 is fully depressed. In this position, bothvacuum and irrigation are turned on, so that kidney stones and/or piecesof kidney stones can be removed.

FIG. 28 shows a mechanism 180 for kidney stone removal according to anembodiment. In FIG. 28 , a user may employ a distal tip steering control182 to position and/or steer a catheter 184 to perform appropriateoperations to break up and/or remove kidney stones. One or more pullwires (not shown) can facilitate positioning and/or steering of thecatheter 184. User control of the trigger 186 controls operation of thetrigger mechanism, described further herein, to control vacuum andirrigation through the catheter 184. A handle portion 188 is sized for auser to hold the mechanism 180, with the user's thumb operating thedistal tip steering control 182 and one of the user's fingers operatingthe trigger 186. Alternatively, a user's thumb may operate the trigger186, and a user's finger may operate the distal tip steering control182. Also in FIG. 28 , a port 190 connects to a vacuum source (notshown). The catheter 184 is attached to a catheter strain relief 192. Inan embodiment, a port 194 provides access to a working channel withinthe catheter 184 to facilitate introduction of therapeutic tools, suchas a laser, to the distal end of the catheter 184. FIG. 29 shows anenlarged view of the distal tip steering control 182 and the trigger186, and an upper portion of the handle portion 188.

FIG. 30 shows an example of a trigger mechanism that may be used in theembodiment of FIGS. 28 and 29 . An irrigation tube 196 has inlet 198,connected to an irrigation source, and an outlet 200, connected to adistal tip (not shown) to irrigate a desired region. Posts 202 arelocated and sized to hold the distal tip steering control 182, which maybe attached to the posts 202 via one or more pins (also not shown)passing through holes 204 in the posts 202. As part of the distal tipsteering control 182, pull wires (not shown) may be provided to guidemovement and position of the catheter's distal tip to perform suitableactions to maneuver the tip into proper position for a kidney stoneremoval procedure. Depression of the trigger 186 causes rotation of thetrigger 186 around pivot pin 206, and causes a roller 208, attached viaa pin 210, to move from the position shown to a location so as to covera port 212, which is connected to ambient air via to an activation tube(not shown). That is, covering the port 212 functions in the same way asthe activation pinch mechanism 96 of FIGS. 35 and 36 in that when theport 212 is covered there is no longer flow from ambient air to thevacuum source. When the port 212 is uncovered, the vacuum is off at thetarget area. When the port 212 is covered, the vacuum is on at thetarget area.

FIGS. 31-34 show progressive depressions of the trigger 186. In thesefigures, for ease of description, posts 202 remain in the same position,that is, the distal tip steering control 182 is not being operated. FIG.31 shows the trigger 186 in an undepressed position. In this position,the roller 208 closes off, or at least constricts, irrigation the tube196, while the port 212 is open. The roller 208 is set apart from acontact edge 214. This position corresponds to the vacuum and theirrigation both being turned off. In FIG. 32 , initial depression of thetrigger 186 causes the trigger 186 to rotate slightly to the rightaround the pivot pin 206, causing the roller 208 to move slightly upwardand to the right. In this position, the irrigation tube 196 is openedfurther, allowing irrigation of the area to be treated. This positioningof the trigger 186 corresponds to an irrigation only state, with vacuumstill turned off by virtue of the port 212 remaining open. In FIG. 33 ,further depression of the trigger 186 causes the trigger 186 to rotateslightly more to the right around the pivot pin 206, causing the roller208 to move slightly more upward and to the right. With the roller 208in this position, the port 212 remains open, so vacuum still is turnedoff. The irrigation tube 196 is squeezed less, allowing for moreirrigation of the affected area. In this position, the roller 208contacts an edge 214, which acts as a detent, according to anembodiment. When the roller 208 contacts the edge 214, the user isalerted, by virtue of encountering resistance to depression of thetrigger 186. In FIG. 34 , when the user overcomes the resistance at theedge 214 and depresses the trigger 186 farther, the trigger 186 rotatesfarther upward and to the right until the roller 208 covers the port212. At this point, the roller 208 is seated in indentation 216, andcannot move farther. In this fashion, the user is aware that the triggerdepression is at maximum. When the trigger 186 is in this position,irrigation remains on, and vacuum turns on, by virtue of the port 212being closed (for example, performing as described in FIGS. 35 and 36 ).

FIGS. 37 and 38 show an embodiment of a mechanism 218 that includes anirrigation bypass structure 220, which functions to always provide aminimum irrigation flow through the mechanism. The irrigation bypassstructure 220 can be implemented with any of the embodiment disclosedabove and is not limited to mechanism 218. FIGS. 37 and 38 show amechanism head 222 having protrusions 224, 226, and 228, which functionas disclosed in other embodiments herein to control irrigation andvacuum/suction using a single trigger 230. In some cases, the user maywish to maintain a minimum irrigation flow through the mechanism 218without having to activate the trigger 230. In some embodiments of themechanism disclosed herein, the protrusion 224 may be implemented suchthat the protrusion 224 does not completely close off the irrigationtube against which the protrusion 224 is positioned. Such animplementation may be suitable for some cases, but in other cases maynot provide a sufficiently well-defined minimum flow rate. That is, theextent of the incomplete closure of the irrigation tube may vary morethan is desired. FIGS. 37 and 38 provide an embodiment in which a morewell-defined minimum irrigation flow can be provided through irrigationbypass structure 220 than via incomplete closure of the irrigation tube.

FIG. 37 shows a flow path FP in which most of the flow of irrigationfluid flows from an inlet 232 through an irrigation tube 234 until theflow is stopped by the protrusion 224 having closed off the irrigationtube 234 by pinching it closed. A lower amount of the flow of theirrigation fluid passes from the inlet 232 through the irrigation bypassstructure 220 and to an outlet 236, which is connected to a distal endof the stone removal device. Thus, in this embodiment at least someirrigation is always flowing to the distal end of the stone removaldevice. FIG. 38 shows a configuration in which the trigger 230 isdepressed, thereby moving the protrusion 224 away from the irrigationtube 234 and opening the irrigation tube 234. With the irrigation tube234 open, irrigation fluid can flow along flow path FP from the inlet232 through the mechanism head 222 and to the outlet 236. Some minoramount of irrigation fluid may still flow through the bypass structure220, but most of the irrigation fluid flows through the mechanism head22.

FIG. 39 shows the irrigation bypass structure 220 having an inlet tube238 that defines an inlet lumen 240, which connects the inlet 232 withthe supply outlet 236 and having an outlet tube 242 that defines anoutlet lumen 244, which connects a return inlet 246 with the outlet 236.An irrigation tube (not pictured) connects the supply outlet 236 withreturn the inlet 246 and carries irrigation fluid through the mechanismhead and trigger activation mechanism of various embodiments disclosedherein. The inlet tube 238 is connected with the outlet tube 242 by abypass 250, which includes a pair of bypass tubes 252 connected by abypass connector 254. FIG. 39 shows the bypass tubes 252 as hose barbsand the bypass connector 254 as tubing, but other equivalentconfigurations of similar structure can be used. The bypass 250 includesflow restrictions 256, which are narrow lumens (narrower than thediameter of the inlet lumen 240) that restrict the amount of irrigationfluid that can flow through the bypass 250. FIG. 39 shows two flowrestrictions 256 because it may be desirable for manufacturingefficiency to produce two of the same parts and connect them via theconnector 254 to form irrigation bypass structure 220, but a single flowrestriction 256 can be sufficient to provide the function of theirrigation bypass structure 220 as disclosed herein. In someembodiments, the inner diameter of the flow restriction 256 can be inthe range of about 5% to about 30% of the inner diameter of the inletlumen 240 and in some embodiments about 20% of the inner diameter ofinlet 240. For example, the flow restriction 256 can have an innerdiameter of about 0.5 mm when the inlet lumen 240 has an inner diameterof about 2.5 mm. Other specific inner diameters within the percentageranges disclosed are within the scope of the bypass structure. As flowrate varies to the fourth power of diameter, the ratio of the innerdiameters of the flow restriction 256 and the inlet lumen 240 directlyinfluence the ration of the flow rate through the trigger mechanism andthrough the bypass structure. Other factors, such as surface tension andpressure drop, may influence the extent to which the flow rate isdominated by this power law relationship.

FIG. 40 shows an irrigation bypass structure 258 of an alternateembodiment viewed in cross section defined by a plane along line C inthe embodiment of similar irrigation bypass structure 220. This bypassstructure can be implemented with any of the embodiments disclosedabove. The irrigation bypass structure 258 includes an inlet tube 260,which defines an inlet lumen 262, and an outlet tube 264, which definesan outlet lumen 266. These lumens are connected by an irrigation tube(not pictured) that carries irrigation fluid through mechanism heads andtrigger activation systems disclosed herein. FIG. 40 shows that theinlet lumen 262 and the outlet lumen 266 are also connected by a bypass268, which is formed by a first bypass fitting 270 and a second bypassfitting 272. The first bypass fitting 270 and the second bypass fitting272 connect via complementary features and form a fluid tight seal viaO-ring 274. When connected, the first bypass fitting 270 and the secondbypass fitting 272 form a conduit for fluid bypass, and this conduitinclude a flow restriction 276 that has a lumen narrower than the inletlumen 262. Thus, the irrigation bypass structure 258 functions toprovide a well-defined minimum irrigation flow rate when the irrigationtube in the mechanism head is closed by the trigger mechanism.

FIG. 41 shows an irrigation bypass structure 278 of another alternateembodiment viewed in cross section defined by a plane along line C inthe embodiment of similar irrigation bypass structures 220 and 258. Thisbypass structure can be implemented with any of the embodimentsdisclosed above. The irrigation bypass structure 278 includes an inlettube 280, which defines an inlet lumen 282, and an outlet tube 284,which defines the outlet lumen 286. These lumens are connected by anirrigation tube (not pictured) that carries irrigation fluid throughmechanism heads and trigger activation systems disclosed herein. FIG. 41shows that the inlet lumen 282 and the outlet lumen 286 are alsoconnected by a bypass 288, which is formed by a first bypass fitting 290and a second bypass fitting 292. The first bypass fitting 290 and thesecond bypass fitting 292 connect via complementary features and form afluid tight seal via compressible member 294, which is formed of aresiliently flexible material and includes an interior flow restriction296. The compressible member 294 is similar to an O-ring or grommet inshape or function in that it provides a fluid tight seal, but it alsoprovides a lumen in the form of the flow restriction 296, which takes apredefined diameter when the first bypass fitting 290 and the secondbypass fitting 292 are connected. This predefined diameter of flowrestriction 6664 is narrower than the diameter of the inlet lumen 282.Thus, the irrigation bypass structure 278 functions to provide awell-defined minimum irrigation flow rate when the irrigation tube inthe mechanism head is closed by the trigger mechanism.

FIG. 42 shows an irrigation bypass structure 298 of another alternateembodiment viewed in cross section defined by a plane along line C inthe embodiment of similar irrigation bypass structures 220, 258, and278. This bypass structure can be implemented with any of theembodiments disclosed above. The irrigation bypass structure 298includes an inlet tube 300, which defines inlet lumen 302, and an outlettube 304, which defines outlet lumen 306. These lumens are connected byan irrigation tube (not pictured) that carries irrigation fluid throughmechanism heads and trigger activation systems disclosed herein. FIG. 42shows that the inlet lumen 302 and the outlet lumen 306 are alsoconnected by a bypass 308, which is formed by a first bypass fitting 310and a second bypass fitting 312. The first bypass fitting 310 and thesecond bypass fitting 312 connect via complementary features and form afluid tight seal via O-ring 314, which is formed of a resilientlyflexible material. The second bypass fitting 312 also includes aninterior flow restriction 316, which has a diameter narrower than thediameter of the inlet lumen 300. Thus, irrigation bypass structure 298functions to provide a well-defined minimum irrigation flow rate whenthe irrigation tube in the mechanism head is closed by the triggermechanism.

The various flow control mechanisms and bypass structures describedherein can alternatively reside in a separate unit from the handle ofthe device. In this scenario, a flexible irrigation tube and a flexiblevacuum line connect the separate unit with the handle. The separate unitcan be controlled by the user via foot pedals, a touchscreen, or othersimilar activation mechanisms. The mechanisms in the separate unit canbe controlled mechanically, electro-mechanically, electromagnetically,or by other similar control methods. In one example, the separate unitis a reusable unit, similar to or included with the control unit 18. Inthis example, control unit 18 provides irrigation fluid and negativepressure to the system in addition to imaging control.

FIG. 43 shows the mechanism 12 for effecting kidney stone removalaccording to an embodiment. The lower portion of the mechanism includesthe stone catcher receptacle 38 in fluid communication with the vacuuminlet 32. FIG. 44 is a rotated and enlarged view of the mechanism 12inside box W of FIG. 43 and shows the location on mechanism 12 of a flowindicator 318. The flow indicator 318 provides a visual (and optionallyaudible) indication of whether air and/or fluid is flowing throughmechanism 12 and out to the vacuum inlet 32. The absence of fluid flowthrough mechanism 12 can indicate that there is a clog somewhere in thefluid path within the stone removal device. The clog could be in thecatheter section or in the mechanism 12, and it can be important toaddress such a clog to prevent overpressure in the kidney caused bycontinuing to irrigate the kidney in the presence of a clog.

FIG. 45 is an exploded view of a stone catcher assembly 320 that isconfigured to be part of mechanism 12 and can be implemented with any ofthe above-described embodiments. A flow indicator 322 is containedwithin a flow indicator housing 324 with an O-ring 326 that seals theflow indicator housing 324 with a flow indicator cover 328, which istransparent or translucent such that a user can observe the movement ofthe flow indicator 322. An axle 330 allows the flow indicator 322 torotate in the presence of flow. Alternate configurations of flowindicators are within the scope of this disclosure, such as anyconfiguration that moves visibly in response to flow within a housing.The flow indicator housing 324 is connected to a stone catcherreceptacle cap assembly 332 by a fluid tight seal, such as with anO-ring 334. The stone catcher receptacle cap assembly 332 is connectedwith a stone catcher receptacle 336 via a stone catcher receptacle seal338. The stone catcher receptacle cap assembly 332 is also connectedwith an inflow assembly 340. In use, the direction of flow of fluid(including kidney stone debris) in the stone catcher assembly 320 isthrough inflow assembly 340, which is connected to the catheter sectionof the stone removal device, and to the stone catcher receptacle 336.Fluid and air are drawn up through stone catcher receptacle filter 342,which keeps debris within the stone catcher receptacle 336, but allowsfluid and air to pass through and eventually into the flow indicatorhousing 324 to interact with the flow indicator 322. Thus, the flowindicator 322 is unlikely to become jammed or stuck with kidney stonedebris. In any embodiment of a flow indicator, the flow indicator shouldbe protected from having its movement stopped by debris interacting withthe flow indicator itself.

FIGS. 46 and 47 are two views of the flow indicator mechanism thatincludes the flow indicator 322 positioned in the flow indicator housing324. Fluid from the stone catcher receptacle 336 enters the flowindicator housing 324 via a flow inlet 344, which is connected with anindicator inlet 346 to introduce fluid into the flow indicator housing324 to interact with the flow indicator 322. Fluid exits the flowindicator housing 324 via an indicator outlet 348 connected with a flowoutlet 350. The flow indicator 322 includes at least two flow indicatorvanes 352 that interact with fluid as it moves from the indicator inlet346 to the indicator outlet 348. The movement of fluid between theindicator inlet 346 to the indicator outlet 348 pushes on the flowindicator vanes 352 and creates movement of the flow indicator 322 bycausing it to rotate around the axle 330. The indicator inlet 346 andthe indicator outlet 348 can be positioned and various places in theflow indicator housing 324 such that the fluid flow interacts with morethan one flow indicator vane 352 on the path between the indicator inlet346 to the indicator outlet 350.

The flow indicator embodiments disclosed herein are one approach topreventing overpressure in the device and/or in the anatomy during akidney stone removal procedure. In addition to or in place of a flowindicator, mechanisms and devices disclosed herein may include apressure relief valve capable of relieving fluid pressure when the fluidpressure exceeds a certain predetermined safety threshold. A pressurerelief valve may be included on the mechanism handle, on the catheter,at the junction between the handle and the catheter, on the fluid supplyline, and/or at the junction of the fluid supply line and handle.

Distal Assembly and Nozzle

Referring back to FIG. 1 , the distal assembly 16 of the insertabletreatment system 10 is flexible and steerable, is configured to applyirrigation, is configured to allow drainage of the irrigation fluid, isconfigured to apply aspiration (which can be referred to as vacuumand/or suction), and includes visualization capabilities, such as atleast one image sensor and at least one light emitting diode (LED). Thecatheter 14 includes one or more lumens and/or other elongate structureswithin the catheter shaft to facilitate the operation of the distalassembly 16. For example, the catheter 14 can contain portions of asteering assembly, such as one or more pull wires. The catheter 14 cancontain one or more vacuum lumens in fluid connection with the handle 12to facilitate aspiration from the distal assembly 16. The catheter 14can contain one or more irrigation lumens in fluid connection with thehandle 12 to facilitate irrigation from the distal assembly 16. Further,these elongate structures can run along the entire length of thecatheter 14 or along a partial length of the catheter 14.

Referring to FIG. 48A and FIG. 48B, each show a perspective view of adistal assembly 400, which is part of the distal section of theinsertable treatment system 10. FIG. 48B illustrates a view of thedistal assembly 400 with the outer member 402 retracted as compared toFIG. 48A. The outer member 402 can be one or more layers of a tubularstructure, and one or more of the layers of the tubular structure can bepart of the outer portion of proximal sections of the catheter's shaft.The layers of the outer member 402 can include a comparatively softerand more flexible outer layer over a comparatively stiffer inner layer.The distal assembly 400 comprises a vacuum lumen 404 defined by a vacuumshaft 406. The distal end of the vacuum shaft 406 terminates at or nearthe distal end of a nozzle tip 408. The nozzle tip 408 includes one ormore irrigation ports 410 and 412. The irrigation ports 410 and 412 havea slotted shape and can direct irrigation fluid forward and laterallyfrom the distal end of the nozzle tip 408. The distal assembly furthercomprises an image sensor 414 and a light source 416 on either side ofthe image sensor 414. The image sensor 414 can be a semiconductor chipdesigned for image capture and the light source 416 can be a lightemitting diode or similar light source. The region around the imagesensor 414 and the light source(s) 416 can be filled with the type ofpotting material commonly used with electronics, provided that thematerial is biocompatible or otherwise suitable for use with a medicaldevice. FIG. 48B illustrates a printed circuit board 418 connected withthe image sensor 414 and the light source(s) 416. The region around theprinted circuit board 418 can also be filled with potting material. FIG.48B also illustrates the distal end of a pull wire 420 that can be usedto steer the distal assembly 16 of the insertable treatment system 10.The nozzle tip 408 includes a recess into which a ferrule or similarfitting on the end of the pull wire 420 can be inserted to provide adistal attachment point for the pull wire 420.

FIG. 49A illustrates a perspective view of multiple parts of the distalassembly 400 and FIG. 49B illustrates a perspective, exploded view ofthe parts of FIG. 49A. The nozzle tip 408 is configured to accept adistal manifold 422 in the interior of the nozzle tip 408. The distalmanifold 422 includes conduits 424, although other examples of thedistal manifold 422 can include more or fewer total conduits. Theconduits 424 function to direct irrigation fluid to the irrigation ports410 and 412. The distal manifold 422 also includes an upper recess 426for accommodating the imaging assembly (or components thereof),including, but not limited to, the at least one printed circuit board418, the at least one light source 416, and the at least one imagesensor 414. The distal manifold 422 also includes a proximal flange 428that provides a structural member to join and seal against the nozzletip 408 on one side and a shaft manifold 430 on the other side. Theseals on either side of the proximal flange 428 can be fluid tight. Thedistal manifold 422 also includes pull wire recesses 432 for attachingthe steering pull wires to the distal assembly 16 to facilitate steeringof the insertable treatment system 10. FIG. 49B illustrates that theshaft manifold 430 includes pull wire lumens 434 and multiple irrigationlumens 436 (only one of the five irrigation lumens 436 illustrated inFIG. 49B is labeled). In some examples of the catheter's 14 shaft, theshaft manifold 430 can extend the entire length of the catheter's 14shaft or only a portion of length of the catheter's 14 shaft. In someexamples of the catheter 14, there is no shaft manifold and the lumendefined by the outer member 402 serves as an irrigation lumen and as apath for steering mechanisms such as pull wires.

FIG. 50A, FIG. 50B, and FIG. 50C illustrate end views of the parts ofthe distal assembly 400. FIG. 50A illustrates the shaft manifold 430with two pull wire lumens 434 and multiple irrigation lumens 436 (onlyone of the five irrigation lumens 436 illustrated in FIG. 4A islabeled). FIG. 50B illustrates the distal manifold 422 with conduits424, the upper recess 426, the proximal flange 428, and the pull wirerecesses 432. FIG. 50C illustrates the nozzle tip 408 with irrigationports 410 and 412.

FIG. 51A and FIG. 51B illustrate two different examples of the nozzletip 408. FIG. 51A illustrates an example of the nozzle tip 408 in whichthe image sensor 414 and light source 416 are mounted on the nozzle tip408 and multiple irrigation ports 410 and 412 are present. This exampleis conceptually similar to the examples illustrated in previous figures.The nozzle tip 408 includes a nozzle lumen 438 that, in some examples,can accommodate the vacuum shaft 406 and, in alternate examples, candefine the vacuum lumen 404. FIG. 51B illustrates an alternative examplein which the image sensor 414 and the light source 416 are mounted on anelongate insertable member 440 that can be slid with respect to thenozzle tip 408, the distal assembly 400, the catheter's 14 shaft, and/orthe insertable system 10. The elongate insertable member 440 includes aworking lumen 442 through which therapeutic or diagnostic devices can beslid with respect to the elongate insertable member 440. Example of suchdevices include, but are not limited to, lasers, sensors, and graspers.Further, the working lumen 442 can allow for the aspiration of fluid andkidney stone fragments while the elongate insertable member 440 is inplace. The insertable elongate member 440 can have an outer diameter offrom about 1 mm to about 4 mm and the working lumen 442 can have aninner diameter of from about 0.3 mm to about 1.5 mm.

FIG. 52A and FIG. 52B illustrate alternative examples of the nozzle tip408. In FIG. 52A, the nozzle tip 408 includes a single image sensor 414and a single light source 416 while in FIG. 52B the nozzle tip 408includes a single image sensor 414 and three light sources 416 (only onelight source 416 is labeled). The arrangement of light sources 416 inFIG. 52B may be preferable in some examples as the arrangement mayprovide more uniform illumination due to the placement of light sources416 on either side of the image sensor 414. FIG. 52A and FIG. 52B eachillustrate six irrigation ports 410 (only one irrigation port 410 islabeled). These irrigation ports 410 are configured to direct fluiddistally and laterally from the nozzle tip 408. In FIG. 52A and FIG.52B, the nozzle tip 408 includes a nozzle lumen 438 that, in someexamples, can accommodate the vacuum shaft 406 and, in alternateexamples, can define the vacuum lumen 404.

FIG. 53A and FIG. 53B illustrate alternative examples of the nozzle tip408. In FIG. 53A and FIG. 53B, the nozzle tip 408 includes the nozzlelumen 438 that, in some examples, can accommodate the vacuum shaft 406and, in alternate examples, can define the vacuum lumen 404. The nozzletip 408 also includes at least one pull wire recess 444. The nozzle tip408 includes a tip manifold 446 that is configured to direct fluid tothe irrigation ports. The tip manifold 446 is in fluid communicationwith one or more irrigation lumens that conduct irrigation fluid fromthe handle 12 and down the catheter 14 and provides a fluid path to eachof the irrigation ports. In FIG. 53A and FIG. 53B, the nozzle lumen 438is offset from the center of the nozzle tip 408. FIG. 53A illustratesslot-shaped irrigation ports 448 and 450. The irrigation ports 448 arelarger than the irrigation ports 450. The interior of each of theirrigation ports 448 and 450 is configured to direct fluid radially awayfrom the central axis of the nozzle tip 408. FIG. 53B illustratescircle-shaped irrigation ports 452 and 454 and they are similarly sized.The irrigation ports 452 are on the front face of the nozzle tip 408.The openings of the irrigation ports 454 are on the front face andextend into the side, lateral wall of the nozzle tip 408. The interiorof each of the irrigation ports 452 and 454 is configured to directfluid radially away from the central axis of the nozzle tip 408. Theconfiguration of the irrigation ports 454 allows the irrigation ports454 to direct fluid more radially outward than the ports 452. In someexamples, the direction of fluid may approximate a spiral directed awayfrom the central axis of the nozzle tip 408 in both the slot-shaped andcircle-shaped examples.

FIG. 54A and FIG. 54B illustrate alternative examples of the nozzle tip408. In FIG. 54A and FIG. 54B, the nozzle tip 408 includes the nozzlelumen 438 that, in some examples, can accommodate the vacuum shaft 406and, in alternate examples, can define the vacuum lumen 404. The nozzletip 408 also includes at least one pull wire recess 444. The nozzle tip408 includes the tip manifold 446 that is configured to direct fluid tothe irrigation ports. The tip manifold 446 is in fluid communicationwith one or more irrigation conduits 456 to provide a fluid path to eachof the irrigation ports. In FIG. 54A and FIG. 54B, the nozzle lumen 438is concentric with the outer diameter of the nozzle tip 408. FIG. 54Aillustrates six circle-shaped irrigation ports 458. The irrigation ports458 can be elliptical-shaped, slot-shaped, or arc-shaped. The openingsof the irrigation ports 458 extend from the front face into the side,lateral wall of the nozzle tip 408. FIG. 54B illustrates fivecircle-shaped irrigation ports 458 and they are similarly sized. Theinterior of each of the irrigation ports 458 is configured to directfluid radially away from the central axis of the nozzle tip 408. Theexit angle for the irrigation ports depicted in FIGS. 54A and 54B isapproximately 45 degrees with respect to the central axis of the nozzletip 408 and the direction of the irrigation fluid away from the nozzletip 408 is radially away from the central axis of the nozzle tip 408.

FIG. 55A and FIG. 55B illustrate alternative examples of the nozzle tip408. In FIG. 55A and FIG. 55B, the nozzle tip 408 includes a nozzlelumen 438 that, in some examples, can accommodate the vacuum shaft 406and, in alternate examples, can define the vacuum lumen 404. The nozzlelumen 438 is offset from the center of the nozzle tip 408. The nozzletip 408 also includes at least one pull wire recess 444. The nozzle tip408 includes the tip manifold 446 that is configured to direct fluid tothe irrigation ports. The tip manifold 446 is in fluid communicationwith one or more irrigation lumens that conduct irrigation fluid fromthe handle 12 and down the catheter 14 and provides a fluid path to eachof the irrigation ports. FIG. 55A illustrates three circle-shapedirrigation ports 458 with an exit angle of about 45 degrees andconfigured to direct fluid radially away from the central axis of thenozzle tip 408 and two elliptical irrigation ports 460 that direct fluidat a 45-degree angle down from the central axis of the nozzle tip 408but not in a radially diverging direction. The openings of theelliptical irrigation ports 460 are on the front face of the nozzle tip408. The openings of the circle-shaped irrigation ports 458 encompassboth the front face and side lateral wall. FIG. 55B illustrates fivecircle-shaped irrigation ports 458 with an exit angle of about 45degrees and configured to direct fluid radially away from the centralaxis of the nozzle tip 408 and two elliptical irrigation ports 460 thatdirect fluid at a 45-degree angle down from the central axis of thenozzle tip but not in a radially diverging direction.

FIG. 56 illustrates a rear, perspective view of the nozzle tip 408(e.g., can be any of the described nozzle tips) with a tip manifold 446that provides a fluid path to various irrigation ports on the distalface of the nozzle tip 408. The nozzle tip 408 also includes a nozzleirrigation lumen 462 that provides a path for fluid from the catheter 14to the tip manifold 446.

FIG. 57 illustrates an alternative example of the nozzle tip 408. Thenozzle tip 408 includes the nozzle lumen 438 that, in some examples, canaccommodate the vacuum shaft 406 and, in alternate examples, can definethe vacuum lumen 404. The nozzle lumen 438 is offset from the center ofthe nozzle tip 408. The nozzle tip 408 also includes at least one pullwire recess 444. The nozzle tip 408 includes the tip manifold 446 thatis configured to direct fluid to the irrigation ports. The tip manifold446 is in fluid communication with one or more irrigation lumens thatconduct irrigation fluid from the handle 12 and down the catheter 14 andprovides a fluid path to each of the irrigation ports. FIG. 57illustrates a slotted irrigation port 464 with an exit angle of about 45degrees and configured to direct fluid radially away from the centralaxis of the nozzle tip 408. The irrigation port 464 has a 140-degree arcthat provides a substantial sweep of fluid. The nozzle tip 408 includestwo elliptical irrigation ports 466 that direct fluid at a 45-degreeangle down from the central axis of the nozzle tip but not in a radiallydiverging direction.

FIG. 58A and FIG. 58B illustrate alternative examples of the nozzle tip408. In FIG. 58A and FIG. 58B, the nozzle tip 408 includes a nozzlelumen 438 that, in some examples, can accommodate the vacuum shaft 406and, in alternate examples, can define the vacuum lumen 404. The nozzlelumen 438 is offset from the center of the nozzle tip 408. The nozzletip 408 also includes at least one pull wire recess 444. The nozzle tip408 includes the tip manifold 446 that is configured to direct fluid tothe irrigation ports. The tip manifold 446 is in fluid communicationwith one or more irrigation lumens that conduct irrigation fluid fromthe handle 12 and down the catheter 14 and provides a fluid path to eachof the irrigation ports. FIG. 58A illustrates two slotted irrigationports 468, each with an exit angle of about 45 degrees and configured todirect fluid radially away from the central axis of the nozzle tip 468.Each irrigation port has an arc of about 70 degrees and are separated bya central region with an arc of about 40 degrees. Together, theirrigation ports 468 can provide a sweep of fluid of about 180 degrees.FIG. 58B illustrates two slotted irrigation ports 470, each with an exitangle of about 65 degrees and configured to direct fluid radially awayfrom the central axis of the nozzle tip 408. Each irrigation port 470has an arc of about 70 degrees and the irrigation ports 470 areseparated by a central region with an arc of about 40 degrees. Together,the irrigation ports 470 can provide a sweep of fluid of about 180degrees. FIGS. 58A and 58B illustrate that the irrigation ports 468 and470 are configured to direct fluid both distally and laterally from thedistal face of the nozzle tip 408.

FIG. 59A and FIG. 59B illustrate alternative examples of the nozzle tip408. In FIG. 59A and FIG. 59B, the nozzle tip 408 includes a nozzlelumen 438 that, in some examples, can accommodate the vacuum shaft 406and, in alternate examples, can define the vacuum lumen 404. The nozzlelumen 438 is offset from the center of the nozzle tip 408. The nozzletip 408 also includes at least one pull wire recess 444. The nozzle tip408 includes the tip manifold 446 that is configured to direct fluid tothe irrigation ports. The tip manifold 446 is in fluid communicationwith one or more irrigation lumens that conduct irrigation fluid fromthe handle 12 and down the catheter 14 and provides a fluid path to eachof the irrigation ports. FIG. 59A illustrates two slotted irrigationports 472, each with an exit angle of about 45 degrees and configured todirect fluid radially away from the central axis of the nozzle tip 408.Each irrigation port 472 has an arc of about 70 degrees and theirrigation ports 472 are separated by a central region with an arc ofabout 40 degrees. Together, the irrigation ports 472 can provide a sweepof fluid of about 180 degrees. FIG. 59A illustrates that the irrigationports 472 are configured to direct fluid both distally and laterallyfrom the distal face of the nozzle tip 408. FIG. 59B illustrates fourslotted irrigation ports 474 and 476, each with an exit angle of about45 degrees and configured to direct fluid radially away from the centralaxis of the nozzle tip 408. Each irrigation port has an arc of about 20degrees. Irrigation ports 474 are separated by a central region with anarc of about 50 degrees. Neighboring irrigation ports 474 and 476 areseparated by a region with an arc of about 40 degrees. Together, theirrigation ports 474 and 476 can provide a sweep of fluid of about 180degrees. FIG. 59A and FIG. 59B illustrate that the irrigation ports areconfigured to direct fluid both distally and laterally from the distalface of the nozzle tip 408.

The various examples of irrigation port configurations presented hereindemonstrate that the nozzle tip can achieve various spray patterns bymanipulating variables such as the size, shape, and number of irrigationports, the exit angles of the irrigation ports, the placement of theirrigation ports on the distal face of the nozzle tip (i.e., entirely onthe distal face or partially on the distal face and partially on thelateral portions of the nozzle tip as shown by the figures). Further,one or more of the irrigation ports may be configured the same as ordifferent from the configuration of one or more of the irrigation portson the same nozzle tip.

FIG. 60 and FIG. 61 each are perspective views of an embodiment of thedistal assembly 400, which is in the distal section of the insertabletreatment system 10. Both FIG. 60 and FIG. 61 illustrate the outermember or an outer hypotube 402 included in the distal assembly 400. Asdisclosed herein, the outer member 402 of the distal assembly 400 caninclude one or more layers of a tubular structure. In FIG. 60 and FIG.61 the outer hypotube 402 can be at least partially covered by a moreflexible outer layer (not pictured). FIG. 60 and FIG. 61 illustrate thevacuum lumen 404 defined by the nozzle tip 408 in the distal assembly400 and defined by a vacuum shaft (not pictured) in portions of thedevice proximal of the distal assembly 400. The nozzle tip 408 in FIG.60 and FIG. 61 includes an angled distal face to reduce the distal-mostsurface area of the nozzle tip 408, which can reduce the likelihood oftrauma to tissue as the device is advanced distally. The edges of thedistal face are radiused or smoothed with curvature as compared to asharply angled corner for the same reason of reducing the likelihood oftrauma. This angled distal face or edges being radiused and smoothed canbe implemented with any of the nozzle tip 408 configurations disclosedabove. The nozzle tip 408 is illustrated to include four irrigationports arranged in two pairs—a pair of upper irrigation ports 412 and apair of lower irrigation ports 410—but in the perspective view of FIG.60 and FIG. 61 only one of each pair is visible. The pairs of irrigationports 410 and 412 have a slotted shape and can direct irrigation fluidforward and laterally from the distal end of the nozzle tip 150. Theimage sensor 414 is set on the nozzle tip 408 and the light source 416can be on either side of the image sensor 414. As with the perviousembodiments, the image sensor 414 can be a semiconductor chip designedfor image capture and the light source 416 can be a light emitting diodeor similar light source. The region around the image sensor 414 and thelight source(s) 416 can be filled with the type of potting materialcommonly used with electronics, provided that the material isbiocompatible or otherwise suitable for use with a medical device.

FIG. 62A and FIG. 62B illustrate a perspective view and a side view,respectively, of an embodiment of the nozzle tip 408 of the distalassembly 400. The nozzle tip 408 includes the pair of upper irrigationports 412 and the pair of lower irrigation ports 410 arranged around avacuum lumen 404. The nozzle tip 408 includes an upper recess 478 thatprovides a place to mount an image sensor and light source. FIG. 62Billustrates the angled distal face of the nozzle tip 408. The nozzle tip408 includes two conduits 480, one on each side of the nozzle tip 408,that provide a fluid path between the irrigation ports 410 and 412 andthe irrigation lumen in the shaft section of the catheter. The nozzletip 408 can include multiple conduits 480. In the example illustrated inFIG. 62A and FIG. 62B, each conduit 480 includes a divider 482 thathelps direct fluid to each of the irrigation ports 410 and 412.Depending on the number of irrigation ports in a nozzle tip, there canbe multiple dividers in a conduit to distribute fluid to the irrigationports. The dimensions of the divider influences the flow characteristicsof the irrigation fluid at each irrigation port and can be varied toachieve the desired flow characteristics at each port.

FIG. 62C illustrates an end view of a nozzle tip 408 and shows that theupper irrigation ports 412 and the lower irrigation ports 410 includefront-facing openings. As disclosed herein, the interior of theirrigation ports 410 and 412 can be angled such that irrigation fluidexits the nozzle tip at a departure angle with respect to the centralaxis of the nozzle tip, as described herein. The irrigation ports 410and 412 can be characterized by their shape, their radial distribution,their departure angle, and their front-facing area, among otherparameters.

In some examples of the nozzle (e.g., any of the nozzle tips 408described above), the radial distribution of irrigation ports is suchthat the irrigation ports are substantially evenly distributed about thecircumference of the nozzle. In some examples (e.g., any of the nozzles408 described above), in a cross-sectional view of the nozzle tip thelargest angle between any two adjacent irrigation ports measured fromcenter to center of each irrigation port is less than about 110 degreesand depends on the number of irrigation ports on the nozzle. With morethan three irrigation ports, there can be a pair of adjacent irrigationports for which the angle measured from center to center of eachirrigation port substantially about 110 degrees and the several otherirrigation ports have angles measured from center to center of eachirrigation port that are substantially less than about 110 degrees.

In some examples of the nozzle (e.g., any of the nozzle tips 408described above), the irrigation ports have a main axis that is at anangle with respect to the central longitudinal axis of the nozzle. Thisangle or the nozzle exit angle can be in the range of from about 30degrees to about 60 degrees and can be referred to as the irrigationport departure angle. Nozzles can be configured with irrigation portshaving different departure angles or identical departure angles as otherirrigation ports on the same nozzle. Sets of irrigation ports can havethe same departure angle, and that angle can be different from anotherset of irrigation ports on the same nozzle. In some preferred examples,the irrigation port departure angle is about 45 degrees. In otherpreferred examples, the irrigation departure port angle is 30 degrees,31 degrees, 32 degrees, 33 degrees, 34 degrees, 35 degrees, 36 degrees,37 degrees, 38 degrees, 39 degrees, 40 degrees, 41 degrees, 42 degrees,43 degrees, 44 degrees, 45 degrees, 46 degrees, 47 degrees, 48 degrees,49 degrees, 50 degrees, 51 degrees, 52 degrees, 53 degrees, 54 degrees,55 degrees, 56 degrees, 57 degrees, 58 degrees, 59 degrees, or 60degrees. In one preferred example, on one nozzle there is one set ofirrigation ports that has a departure angle of 34 degrees and anotherset of irrigation ports that has a departure angle of 50 degrees. Table1 shows the departure angles for pairs of irrigation ports for severaldifferent nozzle designs.

TABLE 1 Departure angles of irrigation ports in certain nozzle designsTop Port Bottom Port Angle Angle Design (degrees) (degrees) L1 39.1541.75 L2 35.05 38.45 L3 26.8 38.35 L4 22.4 39.9 L5 33.25 53.45 K1 45 45K2 45 45 K3 45 45 K4 45 45 K5 45 45 K6 45 45

Hydraulic diameter can be a useful parameter for characterizing variousirrigation port configurations. Generally, hydraulic diameter is usedwhen characterizing flow in non-circular channels in fluid calculationsthat are common for circular channels. If the cross-section is uniformalong a channel length, the hydraulic diameter, D_(H), is defined as:D_(H)=4A/P, where A is the cross-sectional area of the flow and P is thewetted perimeter of the cross-section.

To characterize preferred examples of nozzle tip designs, several nozzletips were fabricated. The nozzle tips included two pairs of irrigationports where the top and bottom (i.e., upper and lower) were symmetricalpairs having the same slotted shape and departure angle. Table 2 showsthe relevant dimensions of several different nozzle designs. The areaand perimeter of each individual port in a pair is shown in the table.

TABLE 2 Dimensions of irrigation ports in certain nozzle designs TopPort Top Port Top Port Bottom Bottom Port Bottom Port Area PerimeterHydraulic Port Area Perimeter Hydraulic Design (mm²) (mm) Diameter (mm²)(mm) Diameter L1 0.046 0.88 0.209 0.058 0.99 0.236 L2 0.069 1.12 0.2470.085 1.22 0.279 L3 0.098 1.42 0.275 0.120 1.52 0.314 L4 0.117 2.870.163 0.142 1.73 0.330 L5 0.117 1.61 0.290 0.142 1.72 0.330 K1 0.2462.09 0.470 0.137 1.99 0.275 K2 0.045 0.96 0.186 0.010 0.43 0.092 K30.079 1.27 0.250 0.029 0.75 0.155 K4 0.164 1.67 0.393 0.077 1.38 0.224K5 0.079 1.27 0.250 0.077 1.38 0.224 K6 0.164 1.67 0.393 0.029 0.750.155

Test samples were built with a representative vacuum lumen and camerawire to approximate the pressure drop and flow characteristics of afully built device.

Flow rate can be determined by measuring the mass of water exiting thenozzle as a function of time. The experimental setup included aconventional saline irrigation bag under a certain pressure (forexample, 2 psi or 4 psi) connected with the catheter and nozzle sectionsof the device. Table 3 shows the results of flow rate testing in gramsper second for several nozzle arrangements.

TABLE 3 Mass flow rate for certain nozzle designs Flow at Flow at Design2 psi (g/s) 4 psi (g/s) K1 1.022 1.745 K2 0.605 0.861 K3 0.663 1.018 K41.033 1.786 K5 0.837 1.367 K6 0.974 1.689 L1 0.665 1.187 L2 0.701 1.027L3 0.906 1.560 L4 0.919 1.612

From empirical analysis of a range of nozzle designs including multipleirrigation ports, the preferred minimum irrigation mass flow rate from asaline bag at 2 psi is about 0.55 g/s and the preferred minimumirrigation mass flow rate from a saline bag at 4 psi is about 0.75 g/s.In a nozzle, each irrigation port contributes 1/N of the total mass flowrate, where N is the number of irrigation ports, and this fraction canbe converted to a percentage. From empirical analysis of a range ofnozzle designs with four irrigation ports, the various irrigation portswere measured as contributing between 15%-30% of the total irrigationmass flow rate as compared to the calculated amount of 25%. In someexamples of the nozzle, the irrigation mass flow rate is substantiallysimilar from each of the irrigation ports. In other examples of thenozzle, the irrigation mass flow can be between two and four timeslarger from some irrigation ports than from others. This asymmetry canbe used advantageously to provide high irrigation mass flow in somedirections from the nozzle.

The area affected by a nozzle design can be empirically determined. FIG.63A illustrates a test apparatus 484 for determining affected areaincluding a flat test surface 486 having a grid pattern onto which isspread a bed of kidney stone fragments 488 or simulated kidney stonefragments having a size range of from about 1.8 mm to 2.0 mm. Apreferred test apparatus includes a bed of kidney stone fragments havingsubstantially uniform sizes. The test apparatus includes a mount 490 foraligning the distal end of the device, including the nozzle 408, at afixed distance above and parallel to the bed of kidney stones on thegrid pattern. Using a pressurized saline bag, irrigation fluid is sentthrough the nozzle for a set time and the area affected by the fluidjetting from the nozzle is calculated using the grid pattern. Pressureon the saline bag can be in the range of from about 0.5 psi to about 6.0psi. In some preferred examples the pressure on the saline bag is 2 psior 4 psi. The nozzle is then rotated about its longitudinal axis by afixed amount, the test is repeated, and the area affected by fluid iscalculated. FIG. 63B shows a top view of a test bed after a test hasbeen run. An area that is void of kidney stone fragments can be seen onthe surface and the area can be measured using the grid pattern on thesurface.

In preferred examples of the test, the nozzle is rotated 90 degrees suchthat the four test runs are able to approximate the three-dimensionalvolume affected by the irrigation port arrangement on the nozzle.Further, the distance of the nozzle above the grid surface can bechanged to approximate a larger or smaller three-dimensional volume. Insome preferred examples, the distance from the nozzle to the gridsurface is about 6 mm. Table 4 shows the results of affected areatesting in millimeters squared for several nozzle arrangements.

TABLE 4 Affected area for certain nozzle designs Top Bottom Left RightDesign (mm²) (mm²) (mm²) (mm²) K1 300  0 321 375 K2 274  0 383  0 K3 279 0 375  98 K4 675  0 466 633 K5  64 130 397 296 L1  0 239 143 208 L2 109196 242 339 L3 426  50 432 434 L4 384 168 384 386

The grid surface test bed approximates a large volume that is open andeffectively infinite as compared to anatomical scale cavities. Anothertest method can be used to approximate a closed system like the renalpelvis or the calyces of a kidney.

In one example of a closed system test apparatus, kidney stone fragmentsor simulated kidney stone fragments having a size range of from about1.8 mm to 2.0 mm are placed into a test tube. The length and diameter ofthe test tube defines the volume of the test cavity. For example, a testtube having a 14 mm diameter and a 100 mm length can approximate aclosed environment with an anatomically relevant scale. The testapparatus includes a fixture or mount for aligning the distal end of thedevice, including the nozzle, concentrically with the cross-section ofthe test tube. The distal end of the nozzle can be advanced andretracted with respect to the end of the test tube while irrigationfluid is applied at a given pressure. The extent of motion of the kidneystone fragments as a function of distance is measured. Table 5 shows theresults of closed environment testing such that the distances in thetable reflect the maximum distance from which a nozzle design can causemotion in stone fragments in the test apparatus when irrigation fluid issupplied at 2 psi.

TABLE 5 Fluidizing distance for certain nozzle designs Distance Design(mm) K1 19 K3 20 K4 22 K5 16 L1 24 L2 15 L3 22 L4 22

Empirical testing of various nozzle configurations disclosure herein hasdemonstrated some preferred performance characteristics for the aspectsof the method in which it is desirable to fluidize kidney stonefragments. The fluid velocity in some preferred examples is in the rangeof from about 0.50 m/s to about 1.50 m/s when the applied pressure is 2psi and preferably is at least about 1.00 m/s. The fluid velocity inother preferred examples is in the range of from about 0.9 m/s to about2.00 m/s when the applied pressure is 4 psi and preferably is at leastabout 1.45 m/s.

FIG. 64 illustrates a cross-sectional view of a portion of a catheter14. The outer member of the catheter 14 includes an outer jacket 492 andan outer hypotube 494. Within the outer member are pull wires 496positioned within pull wire hypotubes 498 such that the pull wires 496are free to slide longitudinally with respect to the pull wire hypotubes498. In some examples, the pull wire hypotubes 498 can be fixed againstthe outer member and on opposite sides of the outer member. In otherexamples, the pull wire hypotubes 498 are fixed only at the distal endof the catheter 14. An electrical cable 500 is also within the outermember and connects the image sensor in the distal assembly with thehandle. The electrical cable 500 is free to move within the outer memberbut is fixed at or near its distal and proximal ends within the outermember. A vacuum shaft 502 that encompasses a vacuum lumen 504 is alsowithin the outer member and connects the vacuum lumen 504 defined by thenozzle tip with the handle 12. The vacuum shaft 502 is also free to movewithin the outer member but is fixed at or near its distal and proximalends within the outer member. The remaining space within the outermember that is not occupied by the pull wire hypotubes 498, theelectrical cable 500, or the vacuum shaft 502 is the irrigation space506 through which irrigation fluid can flow from the handle to theconduits in the distal assembly. Because the electrical cable 500 andthe vacuum shaft 502 are free to move within the outer member, theirrigation space 506 is not a fixed shape. One advantage of thisarrangement is that there is no dedicated irrigation shaft, whichdecreases the number of structures within the catheter shaft assembly14. Fewer structures results in ease of manufacture and increasedflexibility in the catheter shaft assembly. For example, when thecatheter shaft is generally straight, the irrigation space may take thegeneral shape of an annulus between the outer member and the vacuumshaft but when the catheter shaft is curved the irrigation space maytake the general shape of a crescent as the vacuum shaft is pressedagainst the inner wall of the outer member.

Tool Guiding Device

The above catheter advancements have provided the ability to combine thecamera, laser, aspiration, and irrigation components into one system, tostreamline kidney stone removal procedure and reduce the chances ofadverse consequences associated with kidney stone treatment procedures,most particularly the need to repeat the insertion and removal of theureteroscope and the extraction catheter to remove all of the stones.However, a challenge associated with catheter systems has been theinability to maintain a suitable catheter diameter. The consolidation ofcomponents, especially a laser, requires additional channels, whichwould make the catheter larger in profile than desired. Larger diametercatheters can cause more tissue irritation and injury when navigatedthought the ureter, renal pelvis, and renal calyces. In some instances,a large diameter catheter may not be able to access the kidney at allbecause of a narrow and/or tortuous ureter. Accordingly, for maintaininga low catheter profile, existing lumens, such as the vacuum lumen (asdescribed above), can be used for the laser and other tools. The use ofthe vacuum lumen is plausible because it is wide enough to accommodate alaser. Laser fibers have diameters smaller than vacuum lumens (thediameter of the vacuum lumen is much larger than the diameter of theworking channel of traditional ureteroscope that receives the laserdevice). However, this significant difference in diameter causes thelaser fiber to move within the vacuum lumen. Unwanted movement of thelaser fiber prevents the clinician from being able to target stones withprecision. Any side-to-side movement of the laser fiber in the vacuumlumen not only makes it difficult to fragmentize the stones, but alsocan increase the risk of the laser causing damage to nearby tissues. Theembodiments of the tool guiding device provide a tool for allowing,inter alia, a laser to be effectively used with an extraction cathetersystem for fragmenting kidney stones while concomitantly allowing stonesto flow past the laser and through the vacuum lumen.

A vacuum lumen (for e.g., lumen 404 and 504 as described above) of thecatheter and nozzle can be used for insertion and retraction of stonefragmentation-inducing device such as a lithotripsy device or, mostpreferably, a laser lithotripsy device. An inner diameter of the innertube or the diameter of the vacuum lumen (e.g., 404 and 504) needs to belarge enough to accommodate passage of numerous stone fragments withoutclogging. In the embodiments of the present inventions, diameter of thevacuum lumen (e.g., 404 and 504) can be, for example, 2.0 mm to 3.0 mm,or in some configurations about 2.5 mm. Laser fibers and lithotripsydevices, however, have diameters considerably smaller than the vacuumlumen diameter. This significant difference in diameter causes thefragmentation-inducing device to move around or shift, during operation,within the vacuum lumen. The unintended movement of the laser makes itdifficult for the physical to target stones with precision.

Accordingly, the embodiments of the present inventions provide anintermediate device for securing the fragmentation-inducing device(preferably a laser device or fiber) into the vacuum lumen (e.g., 404and 504). The intermediate device is configured to completely prevent orsignificantly minimize the movement of the laser fiber at the distal endof the vacuum lumen, while not impeding the functionality of the vacuumlumen and allowing fluid and solids to flow past the laser fiber. FIG.65 illustrates the intermediate device, referring to herein as a guide508. The guide 508 includes an elongated body or tube 510 that isconfigured to be inserted through a working channel (e.g., port 42 and138) of the handle 12 and through a proximal end of the catheter 14, andpushed through the vacuum lumen (e.g., vacuum lumen 404 and 504) until adistal end of the guide 508 is positioned precisely at or approximatelyadjacent to the distal end of the vacuum lumen (e.g., at end of distalassembly 400 and nozzle tip 408). In one embodiment, the length of theguide 508 is equivalent to length the vacuum lumen in which it is to beplaced. Preferably, the guide 508 is configured such that the distal tipof the guide 508 does not extend beyond the distal end opening of thevacuum lumen 404 (or nozzle tip 408) when the guide 508 is placedcompletely within the vacuum lumen or in operational position—that is,holding the laser tip at the distal end of the vacuum lumen 404 (ornozzle tip 408). The guide 508 includes at least 2 wings, ridges,flanges, or extensions 512, terms which are used herein interchangeably.The wings 512 project or extend out from a distal segment of theelongated body 510. In one embodiment, the wings 512 extend from thedistal segment of the elongate body 510 such that when the elongatedbody 510 is placed at its operational position within the vacuum lumen404, the wings 510 reside at the distal most segment of the vacuum lumen404 of the nozzle tip 408. The wings 510 can be monolithic extensions ofthe elongated body 510—meaning, the body 510 and the wings 512 are madefrom or molded from one piece. Alternatively, the wings 512 can beextension of a smaller tube that is disposed over and attached to thedistal segment of the elongated body 510. A lumen 514 extends though thecenter of the elongated body 510 for receiving thefragmentation-inducing device, preferably a laser fiber. The lumen 514has a diameter for accommodating the laser fiber that is used. In otherwords, the dimeter of the lumen 514 is large enough to allow a laserfiber to be freely inserted therein and retracted therefrom, but smallenough to prevent or significantly minimize any non-rotational orside-to-side movement of the laser fiber. The very distal end of theguide 508, in front of the wings 512, can include knob segment 516having a tapered end of a smaller diameter than the elongated body 510.The knob segment 516 facilitates the insertion of the guide 508 into anaccess port of the handle 12 and vacuum lumen (e.g., 404 and 504). Thevacuum lumen (e.g., 404 and 504) of the nozzle tip 408 can include atapered segment (not illustrated). The knob segment 516 can come intocontact against this smaller tapered end of the nozzle tip 408 to act asa stop and prevent the guide 508 from extending out from the vacuumlumen 404.

FIG. 66 illustrates a front-end view of an embodiment of the guide 508.The guide includes (or consists of) two wings 512 a and 512 b extendingfrom the elongated body 510. The wings 512 a and 512 b are sized toallow the guide 508 to freely glide into and out of the vacuum lumen(e.g., lumens 404 and 504, and nozzle lumen e.g., lumen 438), whilepreventing side-to-side or non-rotational movement of the winged-sectionof the guide 508 within the vacuum lumen (and nozzle lumen). In otherwords, the greatest diameter D of the guide 508, which includes thewidth (i.e., height) of the wings 512, should be slightly smaller thanthe inner diameter of the vacuum lumen to allow the wings 512 totraverse through the vacuum lumen, yet prevent significant side-to-sidemovement of the wings 512 within the vacuum lumen. In one embodiment,the diameter D can match or be about equal to the inner diameter of thevacuum lumen (e.g., vacuum lumen 404 of FIGS. 48A and 48B). Here, thewings 512 can be made from a softer or more pliable plastic materialthat allows the wings 512 to slightly compress when fitted through thevacuum lumen.

While a preferred two-wing design is illustrated in FIG. 66 , the guide508 can include (or consist of) three wings 512 or four wings 512. Whilethe embodiments of the inventions can include any number of wings, a 2to 4 wing design is preferred because a greater number of wings cancause stones to clog the vacuum lumen or be lodged between the vacuumlumen and the elongated body 510, thus encumbering the functionality ofthe vacuum lumen.

FIG. 67 is a general schematic front-end view of the guide 508comprising (or consisting of) four wings 512 a-512 d positioned at thedistal most end of a vacuum tube 518 (or, for example, vacuum shaft 406of FIGS. 48A and 48B) to secure a tip of a laser device or fiber at thedistal tip of the vacuum tube 518. A laser device or fiber 520 isschematically shown positioned in the lumen 514 of the guide 508. Thelumen's 514 restricted diameter, while allowing insertion and retractionof the laser fiber 520 through the guide 508, prevents or significantlyminimizes movement of the laser fiber 520 within the vacuum tube 518that is not intended by the physician. The stability of the laser 520allows the physician to apply laser pulses to a kidney stone with greataccurately, thus effectively fragmentizing the stones while reducing therisk of injury caused by deviated laser pulses. Wings 512 a-512 d shouldbe of sufficient width or height (i.e., distance between the elongatedbody 510 and the vacuum tube 518) to create gaps 522 between the guide508 and the vacuum tube 518. The gaps 522 allow the vacuum lumen toapply suction for removal of fluids, debris, and kidney stone fragmentsduring the entire laser procedure. The number of wings 512 dictates thenumber of gaps 522. For example, two wings 512 provide two large gaps522, three wings 512 provide three intermediate sized gaps 522, and theillustrated four-wing 512 configuration provides four smaller gaps 522.Larger gaps 522 are preferred to minimize the chances of stones becomingclogged or lodged at the entry point or along a distal section of theguide 508.

FIG. 67 shows four wings 512 a-512 d, where the circumferential distanceis the same between any two neighboring wings. That is, the distancebetween each of 512 a-512 b, 512 b-512 c, 512 c-512 d, and 512 d-512 ais equal. In one embodiment, the circumferential distance between twoneighboring wings can be different from the distance of another pair ofneighboring wings (even if there is one shared wing). For example, thedistance between neighboring wings 512 a-512 b and 512 c-512 d can bethe same and the distance between 512 a-512 d and 512 b-512 c can be thesame, but the distance between 512 a-512 b or 512 d-512 c is less thanthe distance between 512 a-512 d or 512 b-512 c. This configurationprovides two small gaps 522 to allow passage of smaller stones and twolarge gaps 522 to allow passage of larger stones that may not have beenable to be removed if the gaps 522 where the same size. In a three-wingconfiguration, the distance between each wing can vary, thus providedthree gaps 522 each having a different size. Alternatively, in athree-wing configuration, the distance between two pairs of theneighboring wings can be the same while the third pair is spaced at adifferent distance. In some embodiments, in lieu or in addition tochanging the distance between the wings 512 to vary the size of the gaps522, widths (distance between the elongated tube 510 and vacuum lumen518) of the wings can vary so provide gaps 522 of different sizes. Byprovided wings 512 having different widths, the position of the laserhead will be shifted relative to the center of the vacuum lumen.Accordingly, in some embodiments, at least two different sized gaps 522can be provided.

FIG. 68 is an embodiment of the wing 512 design. The wing 512 includes amiddle section 512-1 extending into a distal 512-2 and proximal 512-3segments. The length (in the x-direction, i.e., along the longitudinalaxis) of the middle section 512-1 is greater than the length of thedistal 512-2 and proximal 512-3 segments. The middle section 512-1 canhave a constant width (in the y-direction, i.e., along the radial axis).The middle section 512-1 can have a rectangular shape, which allows itto have sufficient surface contact with an inner side of the vacuumlumen to create stability and prevent any unintended shifting of theguide's 508 distal end, where the wings 512 are located. The distal512-2 and proximal 512-3 segments of the wing 34 slope or taper from themiddle section 512-1 to the elongated tube 32. The thickness (in thez-direction) of the wing 512 can be the same along its entire span. Inan alternative embodiment, the thickness (in the z-direction) of thewing 512 can vary so that the wing 512 is tapered along the x- orlongitudinal direction. For example, as best illustrated in FIG. 69A,the wing 512 can have its thickest dimension at its leading, distal endand its thinnest dimension in its proximal end. In one embodiment, thesidewalls of the wing 512 can converge at an angle, as is shown in FIG.69A, to provide the wing 512 with a shape of an isosceles triangle whenviewed from the top. In accordance with another embodiment, asillustrated in FIG. 69B, the longitudinal axis of the wing 512 is notaligned with the longitudinal x-axis of the guide 508. The longitudinalaxis of the wing 512 is rotated with respect to the x-axis of the guide508. In accordance with another embodiment, not illustrated, the wings512 can have a radius of curvature long the longitudinal direction. Thewings 512 can be positioned symmetrically around the elongated body ortube 510, or alternatively, the wings 512 are positioned asymmetricallyaround the elongated body or tube 510.

FIG. 70 illustrates another embodiment of the guide 508. The guide 508includes a distal end section 524 that is configured to extend out ofthe vacuum lumen (e.g., lumen 404 and 438 or nozzle tip 408) when theguide 30 is placed in position. The distal end section 524 can be a softtip, for example. The wings 512 are positioned proximal to the distalend section 524 but are intended to reside at the distal end segment ofthe vacuum tube.

The guide 508 fixedly supports the head of the laser fiber at the distaltip of a vacuum lumen or nozzle tip while allowing the vacuum lumen toaspirate stones, debris, and fluids during the laser procedure andconcomitantly with the fragmentation of kidney stones. However, thepresence of the guide 508 reduces the inner working diameter of thevacuum lumen. Thus, the guide 508 increases the chance of larger sizedstones gathered and/or becoming lodged at the entry point of the vacuumlumen, as well as in the gaps 522 or between the wings 512. Suchclogging can reduce evacuation efficiency and require manual debrisclearance or increasing internal pressures. The flow indicator 322 ofhandle 12 (as described above) can provide feedback to a user ofclogging and reduction in evacuation. Accordingly, a device can be usedto cause back-and-forth movement, vibration, or oscillation of the guide508 to clear or extricate lodged or clogged stones. Minor back-and-forthmovement of the guide 508 can be effective at dislodging debris andclearing the vacuum lumen. In accordance with one embodiment, asillustrated in FIGS. 71A and 71B, an actuator 526 is provided that canbe permanently attached to or removable coupled with the guide 508. Theactuator 526 can include a biasing band 528. The biasing band 528 is aself-resetting body, such that the inward compression (i.e., squeezing)and release of the band 528 can cause the back-and-forth movement of theguide 508 and the wings 512 within the vacuum lumen (for e.g., lumen 404and 438). A shaft 530 has one end penetrating through a hole 532 of theband 528. The shaft 530 can be fixedly secured to the band 528 by twopairs of opposing tabs 534 extending from the shaft 530. A cylindricalhousing 536 receives an opposing end of the shaft 530. The shaft 530 canmove telescopically, back-and-forth, within the cylindrical housing 536when the band 528 is compressed and released. The cylindrical housing536 is coupled to the opposing side of the band 528 to which the shaft530 is coupled. The shaft 530 can include a shaft head 537 that can bepermanently attached to a proximal tail of the guide 508, oralternatively, the shaft head 537 can be configured to be able to beremovably coupled to the proximal tail of the guide 508. For example,the shaft head 537 and the proximal tail of the guide 508 can havefemale/male coupling members. A tubular member 538 can extend from theproximal end of the cylindrical housing 536. The member 538 can beconfigured to connect to and disconnect from a handle (e.g., handle 12described above) of a catheter. An access channel 540 can extend fromthe member 538, the cylinder housing 536, and the shaft 530 andcommunicate with the lumen 514 of the guide 508. The laser fiber can beinserted into the inlet opening of the access channel 540, fed throughthe actuator 526, and inserted into the lumen 514 of the guide 508. Thelaser fiber can be pushed through the lumen 514 of the guide 508 untilthe laser's head reaches the distal tip of the vacuum lumen (or nozzletip), where wings 512 of the guide 508 prevent any unintended movementof the laser's head.

FIG. 72 illustrates another embodiment of an actuator 542. The actuator542 can be permanently attached to or removably coupled with the guide508. The actuator 542 can include a first (or as oriented in the figure,an upper or distal) lever 544 coupled to a second (or lower or proximal)lever 546 via a fulcrum bar 548. The actuator 542 is self-resetting,such that the inward compression (i.e., squeezing) and release of levers544 and/or 546 can cause the back- and forth movement of the guide 508and the wings 512 within the vacuum lumen (for example, lumen 404 and428). A shaft 550 is coupled to the upper lever 544 and extends out ofan opening of the upper lever 544. A cylindrical housing 552 receives anopposing end of the shaft 550. The shaft 550 can move telescopically,back-and-forth, within the cylindrical housing 552 when levers 554and/or 546 are compressed and released. The cylindrical housing 552 iscoupled to the lower lever 546. The shaft 550 includes a shaft head 554that can be permanently attached to a proximal tail of the guide 508, oralternatively, the shaft head 554 can be configured to be able to beremovably coupled to the proximal tail of the guide 508. For example,the shaft head 554 and the proximal tail of the guide 508 can havefemale/male coupling members. A tubular member 556 can extend from theproximal end of the cylindrical housing 552. The tubular member 556 canbe configured to connect to and disconnect from a handle (e.g., handle12 described above) of a catheter. A channel 558 is accessible from themember 556, and can extend from the member 558, the cylindrical housing552, and the shaft 550, and communicate with the lumen 514 of the guide508. The laser fiber can be inserted into the inlet opening of theaccess channel 558, fed through the actuator 542, and inserted into thelumen 514 of the guide 508. The laser fiber can be pushed through thelumen 514 of the guide 508 until the laser's head reaches the distal tipof the vacuum lumen or nozzle tip, where the wings 512 of the guide 508prevent any unintended movement of the laser fiber's head. In operation,if the actuator 542 is squeezed inward at position P1 (e.g., the upperlever 554 and lower lever 546 are pinched towards each other), the shaft550 actuates outwards (upwards in the illustration) and away from thelower lever 546). Here, the upper lever 544 and/or lower lever 546 pivotabout the fulcrum arm 548 to create a wider gap between the levers544/546 at the shaft end of the actuator 542 and a smaller gap betweenthe levers 544/546 at the end labeled position P1. If the actuator 542is squeezed inward at position P2, (e.g., the upper lever 554 and lowerlever 546 are pinched towards each other or the upper lever 554 ispushed downwards towards the lower lever 546), the shaft 550 actuatesinwards (downwards in the illustration) and towards the lower lever546). Here, the upper lever 544 and/or lower lever 546 pivot about thefulcrum arm 548 to create a smaller gap between the levers 544/546 atthe shaft end of the actuator 542 and a wider gap between the levers544/546 at the end labeled position P1. Thus, the movement of the shafthead 554 can be either away from or towards the lower lever 546 based onthe force that is applied either at P1 or P2.

For the treatment of kidney stones, the catheter can be directed intothe kidney with a use of guidewire. The guide 508 can be inserted intothe vacuum lumen before the insertion of the catheter into the patient.The lumen 514 of the guide 508 can be used to receive the guidewire fornavigating the catheter over the guidewire. Alternatively, the guide 508can be inserted into the catheter at any time during the procedure,including when the catheter has reached its intended position. If aguidewire is with the lumen 514, the guidewire is removed followed byinsertion of the laser fiber. The laser fiber is directed through thelumen 514 of the guide 508 until the laser's head reaches the end of theknob 516. A physician can apply laser pulses to kidney stonesconcomitantly with aspirating debris, stones, and fluids through thecatheter and nozzle vacuum lumen. Should any stones become lodged at theopening of the guide 508, the actuator 526 or 542 can be used to movethe guide 508 within the vacuum lumen to dislodge the stones. After thelaser procedure, the guide 508 can be removed and the vacuum lumen canbe used for the extraction of the remaining un-fragmented or fragmentedstones for the treatment of kidney stones.

The various examples, aspects, and embodiments of the kidney stoneremoval systems disclosed herein provide various advantages when used totreat kidney stones. One advantage is the ability to prevent or tomitigate the possibility of overpressurizing the kidney during kidneystone treatment. In conventional laser lithotripsy of kidney stones,irrigation fluid can be introduced during ureteroscopy and/or duringlaser lithotripsy. In most cases, the irrigation fluid can drain out ofthe kidney only via the narrow space between the ureteroscope and theaccess sheath. This narrow space can become narrowed further by debrissuch as kidney stone fragments, clots, or other substances. When theegress of fluid from the kidney is limited by such a narrow space,continued infusion of irrigation fluid creates the risk of highpressures in the kidney, which can cause sepsis and/or othercomplications. The kidney stone removal system disclosed herein providesa much larger egress channel via the large diameter vacuum lumen.Further, it is possible to apply vacuum through the large diametervacuum lumen while introducing irrigation fluid. The large diameter ofthe vacuum lumen in combination with the ability to apply vacuum whiledelivering irrigation fluid significantly reduces the likelihood ofoverpressurizing the kidney, resulting in safer kidney stone removalprocedures.

Another advantage of the kidney stone removal systems disclosed hereinis the ability to prevent or mitigate thermal damage to the kidneyduring laser lithotripsy. Heat is generated within the kidney duringlaser lithotripsy of kidney stone, in particular with higher powerlasers. This heat can be damaging to the kidney and is a concern forphysicians when performing laser lithotripsy. Irrigation fluid can helpdissipate the heat via conductive heat transfer, but as described hereinirrigation fluid can also build up within the kidney if the pathway fordraining is relatively narrow. The kidney stone removal system disclosedherein provides a much larger egress channel via the large diametervacuum lumen in combination with the ability to apply vacuum whiledelivering irrigation fluid. The kidney stone removal system disclosedherein can maintain a safe temperature within the kidney by rapidlyremoving heated irrigation fluid from the kidney and introducingrelatively cooler irrigation fluid in a continuous manner during laserlithotripsy. In the examples, aspects, and embodiments of the kidneystone removal system that include a laser guide, heated irrigation fluidcan easily and rapidly flow through the vacuum lumen even while thelaser fiber is being used to fragment kidney stones and comparativelycooler irrigation fluid can easily and rapidly enter the kidney via theirrigation ports on the nozzle. This rapid heat transfer via irrigationfluid rapidly introduced and removed from the kidney significantlyreduces the likelihood of thermal damage to the kidney, resulting insafer kidney stone removal procedures.

Another advantage of the kidney stone removal systems disclosed hereinis the ability to improve visibility in the kidney during laserlithotripsy. In conventional laser lithotripsy, debris from fragmentingkidney stones frequently obscures the view from the imaging portion of aureteroscope and makes it difficult for a physician to see areas ofinterest within the kidney and/or the kidney stones being fragmented.Physicians often describe a “snow globe” effect during laser lithotripsyin which debris is ejected from the kidney stone in a random and chaoticmanner that quickly fills their field of view. The kidney stone removalsystem disclosed herein can improve visibility by rapidly removingdebris fluidized in the irrigation fluid from the kidney through thelarge diameter vacuum lumen and introducing clear irrigation fluid in acontinuous manner during laser lithotripsy. In the examples, aspects,and embodiments of the kidney stone removal system that include a laserguide, debris suspended or fluidized in irrigation fluid can easily andrapidly flow through the vacuum lumen even while the laser fiber isbeing used to fragment kidney stones. Further, rather than a random andchaotic field of view, the kidney stone removal system disclosed hereinprovides a predictable pattern as debris moves in a regular motionacross the field of view to the vacuum lumen. Such a regular patternmakes it easier for a physician to stay oriented with anatomicallandmarks in the field of view. Still further, because of thecomparatively large egress channel (as compared to the narrow channelbetween the ureteroscope and access sheath) more debris is removed andremoved faster using the kidney stone removal system disclosed herein.In some cases, even with little or no applied vacuum the large diameterof the vacuum lumen creates sufficient passive outflow to substantiallyimprove visibility. The large diameter of the vacuum lumen incombination with the ability to apply vacuum while delivering irrigationfluid and in combination with the regular debris flow patternsignificantly improves visibility during laser lithotripsy, resulting insafer, more efficient, and more effective kidney stone removalprocedures.

Another advantage of the kidney stone removal systems disclosed hereinis the ability to rapidly apply and remove therapeutic or diagnosticagents in the kidney during laser lithotripsy. The irrigation fluid canhave chemical or biological agents applied to it from the source bag orusing a port adjacent to the system handle. These agents can betherapeutic, such as, but not limited to, hemostatic, antibiotic, and/orlytic agents. And these agents can be diagnostic, such as, but notlimited to, contrast agents.

Another advantage of the kidney stone removal systems disclosed hereinis the orientation of the irrigation ports with respect to the distalend of the vacuum lumen. The irrigation ports deliver irrigation fluidat a departure angle with respect to the central axis of the crosssection of the vacuum lumen. This angle, in combination with the vacuumapplied via the vacuum lumen, creates a flow pattern that affects avolume much larger than the diameter of the distal end of the device.And this flow pattern can be regular rather than turbulent and canreduce, mitigate, and/or eliminate vortices that can form whenconventional ureteroscopes deliver fluid to a kidney. Further, it hasbeen empirically shown that irrigation ports that deliver fluid in astraight line distally from the end of the ureteroscope tip can pushdebris away from the distal tip, which makes it difficult to aspiratethe debris. In contrast, the kidney stone removal systems disclosedherein can bring debris closer to the vacuum lumen by producing regularflow patterns that initially diverge away from the nozzle and returnback to the central axis of the nozzle at distance from the distal endof the nozzle. The kidney stone removal systems disclosed herein do notneed to be pointed directly at kidney stone fragments to affect them andto bring them close to the vacuum lumen. Thus, the effective area of thekidney stone removal systems disclosed herein is significantly greaterthan the area directly in front of the nozzle and this effective areacan be used to clear calyces of debris without the nozzle being pointeddirectly at the debris.

Another advantage of the kidney stone removal systems disclosed hereinis that the irrigation ports can provide a flow rate independent of thetool being used within the vacuum lumen. Conventional ureteroscopestypically provide irrigation through the working channel and this sameworking channel is used to provide access for laser fibers or baskets.The presence of a tool within the working channel alters the fluiddynamics and changes the flow rate and other flow characteristics. Incontrast, the kidney stone removal systems disclosed herein deliversirrigation fluid via dedicated irrigation ports such that the flowcharacteristics are independent of the tool being used, if any, in thevacuum lumen.

As used herein, connected, attached, coupled or in communication withare terms which can be used interchangeably and when a feature orelement is referred to herein as being connected, attached, coupled orin communication with to another feature or element, it can be directlyconnected to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being directly connected to another feature or element,there are no intervening features or elements present.

When a feature or element is referred to herein as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being directly onanother feature or element, there are no intervening features orelements present.

Although the above descriptions refer to “embodiments,” any one of theabove-described features or embodiments can be use, implemented, orcombined with any other of the features or embodiments describedherewith.

As used herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise.

It will be further understood that the terms “comprises” and/or“comprising,” when used in this specification, specify the presence ofstated features, steps, operations, elements, and/or components, but donot preclude the presence or addition of one or more other features,steps, operations, elements, components, and/or groups thereof.

As used herein, the term “and/or” includes any and all combinations ofone or more of the associated listed items and may be abbreviated as“/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

When a feature is said to be disposed “adjacent” another feature, it maybe positioned next to the other feature without any overlapping orunderling portions, or it may have portions that overlap or underlie theadjacent feature.

The spatially relative terms, “proximal,” “distal,” and the like, may beused herein for ease of description to describe one element's orfeature's relationship to another. It will be understood that proximaldescribes a spatial location closer to the user or the intended positionof the user while distal describe a location farther from the user orthe intended position of the user. Further, when used with respect to aminimally invasive device like a catheter, proximal and distal locationsrefer to the portion of the device that is intended to be closer to orfarther from the user, respectively, and do not change when the deviceis in use.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element could betermed a second feature/element, and similarly, a second feature/elementcould be termed a first feature/element without departing from theteachings of the present invention.

As used herein including as used in the examples and unless otherwiseexpressly specified, all numbers may be read as if prefaced by the word“about” or “approximately,” even if the term does not expressly appear.The phrase “about” or “approximately” may be used when describingmagnitude and/or position to indicate that the value and/or positiondescribed is within a reasonable expected range of values and/orpositions. For example, a numeric value may have a value that is +/−0.1%of the stated value (or range of values), +/−1% of the stated value (orrange of values), +/−2% of the stated value (or range of values), +/−5%of the stated value (or range of values), +/−10% of the stated value (orrange of values), etc. Any numerical values given herein should also beunderstood to include about or approximately that value, unless thecontext indicates otherwise. For example, if the value “10” isdisclosed, then “about 10” is also disclosed. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.It is also understood that when a value is disclosed that “less than orequal to the value,” “greater than or equal to the value” and possibleranges between values are also disclosed, as appropriately understood bythe skilled artisan. For example, if the value “X” is disclosed the“less than or equal to X” as well as “greater than or equal to X” (e.g.,where X is a numerical value) is also disclosed. It is also understoodthat the throughout the application, data is provided in a number ofdifferent formats, and that this data, represents endpoints and startingpoints, and ranges for any combination of the data points. For example,if a particular data point “10” and a particular data point “15” aredisclosed, it is understood that greater than, greater than or equal to,less than, less than or equal to, and equal to 10 and 15 are considereddisclosed as well as between 10 and 15. It is also understood that eachunit between two particular units are also disclosed. For example, if 10and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

Disclosed herein are systems, devices, and methods for the guidedremoval of objects in vivo. In particular, the systems, devices, andmethods may be adapted to traverse compact areas, such as the urinarytract, and to remove debris, such as kidney stones or fragments ofkidney stones, via aspiration through a vacuum tube. As used herein, theterm “kidney stones” may refer to fragments of kidney stones, includingfragments that have been created by therapeutic fracturing of kidneystones, such as with the device described herein or by another device.The term “kidney stones” may refer to stone or fragments of stoneslocated in the ureter as well as in the kidney and the systems, devices,and methods disclosed herein may be capable of removing kidney stonesfrom the kidney or ureter.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived therefrom, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

It is understood that this disclosure, in many respects, is onlyillustrative of the numerous alternative device embodiments of thepresent invention. Changes may be made in the details, particularly inmatters of shape, size, material and arrangement of various devicecomponents without exceeding the scope of the various embodiments of theinvention. Those skilled in the art will appreciate that the exemplaryembodiments and descriptions thereof are merely illustrative of theinvention as a whole. While several principles of the invention are madeclear in the exemplary embodiments described above, those skilled in theart will appreciate that modifications of the structure, arrangement,proportions, elements, materials and methods of use, may be utilized inthe practice of the invention, and otherwise, which are particularlyadapted to specific environments and operative requirements withoutdeparting from the scope of the invention. In addition, while certainfeatures and elements have been described in connection with particularembodiments, those skilled in the art will appreciate that thosefeatures and elements can be combined with the other embodimentsdisclosed herein.

1.-9. (canceled)
 10. A kidney stone removal mechanism, comprising: anirrigation tube; a vacuum tube; and a trigger mechanism including atrigger operable by a user, the trigger located at a proximal end of thekidney stone removal mechanism, the trigger mechanism operable toselectively constrict, close, and open the irrigation tube to irrigatean area of treatment upon user operation of the trigger, and toselectively initiate vacuum within the vacuum tube to remove partial orentire kidney stones upon user operation of the trigger, wherein thetrigger comprises a first protrusion, such that user operation of thetrigger causes the first protrusion to selectively constrict, close, andopen the irrigation tube, a second protrusion, such that user operationof the trigger causes the second protrusion to selectively initiatevacuum within the vacuum tube, a third protrusion, such that the triggermechanism comprises a first detent, selectively engageable with thethird protrusion, to alert the user to a predetermined amount ofdepression of the trigger.
 11. The kidney stone removal mechanism ofclaim 10, wherein the first detent comprises an edge of a protrusioninside the trigger mechanism.
 12. The kidney stone removal mechanism ofclaim 10, wherein the first detent comprises an edge of a depressioninside the trigger mechanism.
 13. The kidney stone removal mechanism ofclaim 10, wherein the third protrusion comprises a roller.
 14. Thekidney stone removal mechanism of claim 10, further comprising a seconddetent to alert the user to a full amount of depression of the trigger.15. The kidney stone removal mechanism of claim 14, wherein the seconddetent comprises a protrusion inside the trigger mechanism.
 16. Thekidney stone removal mechanism of claim 14, wherein the second detentcomprises an opposite edge of a depression inside the trigger mechanism,the third protrusion engaging with the opposite edge of the depressionto alert the user to a full amount of depression of the triggermechanism. 17.-22. (canceled)
 23. A kidney stone removal mechanismcomprising: an irrigation tube configured carry fluid and having aportion passing within a trigger mechanism; and a bypass structureconnected in two places with the irrigation tube and configured to allowfluid to flow from a first part of the irrigation tube to a second partof the irrigation tube without passing through the portion of theirrigation tube within the trigger mechanism; wherein the triggermechanism includes a trigger operable by a user, the trigger mechanismoperable to selectively constrict, close, and open the first irrigationtube to irrigate an area of treatment upon user operation of thetrigger.
 24. The kidney stone removal mechanism of claim 23, wherein thebypass structure comprises a flow restriction.
 25. The kidney stoneremoval mechanism of claim 23, wherein user depression of the triggerprogressively opens the irrigation tube.
 26. The kidney stone removalmechanism of claim 23, further comprising a vacuum tube configured to beactivated by the trigger mechanism.
 27. The kidney stone removalmechanism of claim 23, further comprising: a catheter connected at itsproximal end to a distal end of the kidney stone removal mechanism, thecatheter having a distal tip at a distal end of the catheter; and asteering mechanism, located at the proximal end of the kidney stoneremoval mechanism, the steering mechanism operable to steer the distaltip to facilitate removal of partial or entire kidney stones. 28.-66.(canceled)